Nasus Pharma

Nasus Pharma to Present Positive Clinical Results from Recent studies of FMXIN002 (NS002) Intranasal Epinephrine at the 2025 AAAAI Annual Meeting

nasuspha_admin — Fri, 28 Feb 2025 10:39:38 +0000

Tel Aviv, Israel. Feb, 27, 2025 — Nasus Pharma Ltd. (“Nasus Pharma” or the “Company”), a clinical-stage biopharmaceutical company focused on developing needle-free, powderbased intranasal (“PBI”) products addressing acute, community based, medical conditions, today announced that it will be presenting the results of two of its clinical studies at the 2025 American Academy of Allergy, Asthma and Immunology (“AAAAI”) Annual Scientific Meeting, taking place from February 28 to March 3, 2025, in San Diego, California.

Nasus Pharma will be presenting integrated data, including pharmacokinetics and pharmacodynamics, of intranasal epinephrine in healthy volunteers and under allergenic conditions in atopic patients.

“We are excited to share the integrated efficacy and safety data from our initial studies during the AAAAI’s upcoming meeting. We look forward to collaborating with the medical community as we continue to develop our Epinephrine program, which we believe offers important advantages over existing therapies, to address what we believe is an important medical need for millions of people who suffer from severe allergies,” said Dan Teleman, Nasus Pharma’s Chief Executive Officer

Information about Nasus Pharma’s poster presentation can be found below. Attendees are encouraged to visit our poster presentation to learn more about FMXIN002. Abstracts can be viewed at annualmeeting.aaaai.org.

Poster Presentation – March 1, 2025

Time: 9:45 a.m. – 10:45 a.m. PST
Title: Fast Acting, 5 years stable Intra-Nasal Powder Spray Epinephrine for
Anaphylaxis: Integrated Analysis of Two Clinical Trials
Authors: Tair Lapidot, PhD, Yuval Tal, MD, PhD, Dalia Megiddo, MD, Galia
Temtsin Krayz, PhD, Yoseph Caraco, MD
Poster ID: 293

About FMXIN002
FMXIN002, also known as NS002, is a powder formulation of epinephrine nasal spray developed by Nasus Pharma based on its unique intranasal powder proprietary technology. The company believes that the FMXIN002 may enable people to deliver epinephrine in emergency situations easily, rapidly, and with less hesitation, at the onset of an allergic reaction, as compared to currently available epinephrine self-injectors. FMXIN002 uses APTAR Nasal Unidose Powder device – an intuitive and easy-to-use device with 360° functionality and precise one-dose nasal drug delivery.

Anaphylaxis is a severe, life-threatening allergic reaction with a sudden onset that can occur within a few minutes, and unless treated promptly, could be fatal. Some 5 million people in the United States are at risk of having an anaphylaxis reaction. Over 200,000 emergency room visits due to severe reactions from food allergies are reported annually.

About Nasus Pharma
Based on its unique microsphere technology, Nasus Pharma is developing a number of intranasal powder products addressing acute emergency situations in the community such as anaphylactic shock and opioid overdose.

Intranasal administration is most suitable for those situations in which rapid drug delivery is required and offers multiple advantages such as rapid drug delivery, ease of use, noninvasiveness, and safety. Nasus portfolio comprises a number of programs in different stages of development.

Contact:
Info@nasuspharma.com
Nasus Pharma Ltd. Israel
Tel: +972547707807
https://www.nasuspharma.com

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Nasus Pharma Announces Ground-Breaking Five Years Stability of its FMXIN002 Nasal Epinephrine Powder for Severe Allergy and Anaphylaxis

sitrus — Wed, 07 Aug 2024 06:54:31 +0000

Nasus Powder Epinephrine offers long term stability as well as rapid and higher epinephrine absorption- changing the face of anaphylactic shock treatment

Tel Aviv, Israel August 6th 2024– Nasus Pharma Ltd a clinical-stage biopharmaceutical company focused on developing needle-free, powder-based Intranasal (PBI) product portfolio, to address acute medical conditions announced the results of a 5 years stability study of its FMXIN002 drug candidate – nasal powder epinephrine for the treatment of severe allergy and anaphylactic shock.

FMXIN002 is an investigational intranasal epinephrine powder spray device that is noninvasive, needle-free, user-friendly, and reliable and could provide timely effective rescue for severe potentially life-threatening allergic reactions to food, medications, and insect bites.

FMXIN002 stored 5-year at room temperature (15-25° Celsius) showed full stability of the nasal powder and device. Epinephrine base was 97.5% at 5 years well within the defined limits (95-105% ICHQ1 ). The levels of degradation products were 0.37% which is significantly below the maximum level of 4 % defined for the low-dose (<10 mg) producta. In addition, the enantiomeric purity was found to be 100%,. These results are in line with prior results of FMXIN002 showing full stability after 6 months in accelerated conditions (40° Celsius and 75% humidity ). These findings are also in line with a prior study that compared FMXIN002 with Epipen autoinjectors showing 100% Epinephrine enantiomeric purity in FMXIN002 vs 1.9% S-Epinephrine impurity found in Epipen injector ( below allowed level of 3%) and 3.8 % of S-Epinephrine impurity found in Junior Epipen injectors ( above allowed level). Both autoinjectors were still prior to their expiration date.

Epinephrine, the mainstay of immediate treatment for severe allergy and anaphylaxis is known to be unstable in liquid form requiring the addition of multiple excipients and stabilizers some of which may be associated with added safety concerns. Epinephrine in solution carries between 12-18 months expiration dates. FMXIN002 is a proprietary powder dosage form that requires no stabilizers and offers extremely long stability period and excellent safety profile.

The long stability of Epinephrine carries meaningful advantages both for patients (currently need to replace injectors on average every 12 months) and healthcare payors given the high costs of Epinephrine autoinjectors. Additionally, the stability of FMXIN002 under extreme conditions of heat and humidity enables carrying the FMXIN002 inhaler during daily activities and avoiding the need to shield the inhaler from heat and humidity

Lately, Nasus Pharma published the results of its phase 2 clinical study demonstrating the clear advantage of its FMXIN002 inhaler in creating quicker and higher levels of Epinephrine in the blood compared to Epipen autoinjector, especially in the first 30 minutes – when prompt treatment in Epinephrine is critical.

Importantly the pharmacokinetics of the powder-based intranasal epinephrine were able to abate multiple concerns recently raised within the medical community as to the adequacy of other albeit solution-based nasal epinephrine products in development with regards to the protection in the immediate period following the development of anaphylactic shock: FMXIN002 demonstrated clear and meaningful advantage both in the pharmacokinetic profile of the first 20-30 minutes and in the number of patients reaching drug plasma clinical threshold of Epinephrine. ( 91% in the first 6 minutes).

“The results of our long-term stability study as well as the results from our phase 2 clinical study are further confirmation of the advantages of our proprietary powder intranasal epinephrine FMXIN002 in offering easy to use reliable small device that can be carried around in a small pocket and is a highly effective immediate treatment for anaphylactic shock” – Said Dr. Dalia Megiddo, Nasus Pharma CEO.

Udi Gilboa, Executive Chairman of the Board added:
“ We are extremely encouraged by the data generated by the company up-until today including the latest outstanding results showing unheard of Epinephrine stability of 5 years.

The commercial potential of our Powder-Based Epinephrine product and its potential to become the fastest-acting simple-to-administer, needle-free nasal spray, provides patients and caregivers with the most promising alternative for this growing Type I allergic reaction market.

The stability of our FMX002 powder inhaler is financially meaningful as the current alternatives in the market of solution-based Epinephrine have only 12-18 month stability. Powder-based products are also known to have better stability, as compared to solutionbased products. Yet an additional advantage for powder-based formulation of epinephrine , a drug that undergoes rapid degradation in the currently-available short shelf-life liquid dosage forms.”

About FMXIN002

FMXIN002 is a powder formulation of epinephrine nasal spray developed by Nasus Pharma based on its unique intranasal powder proprietary technology. The company believes that the FMXIN002 may enable people to deliver epinephrine in emergency situations easily, rapidly, and with less hesitation, at the onset of an allergic reaction, as compared to currently available epinephrine auto-injectors. FMXIN002 uses APTAR Nasal Unidose Powder device – an intuitive and easy-to-use device with 360° functionality and precise one-dose nasal drug delivery.

Anaphylaxis is a severe, life-threatening allergic reaction with a sudden onset that can occur within a few minutes —and unless treated promptly could be fatal . Some 5 million people in the United States are at risk of having an anaphylaxis reaction. Over 200,000 emergency room visits due to severe reactions from food allergies are reported annually.

About Nasus Pharma

Based on its unique microsphere technology, Nasus Pharma is developing a number of intranasal powder products aimed at assisting patients in several acute emergency situations such as opioid overdose and anaphylactic shock. Intranasal administration is most suitable for those situations in which rapid drug delivery is required and offers multiple advantages such as rapid drug delivery, ease of use, noninvasiveness, and safety. Nasus portfolio comprises a number of programs: Intranasal Naloxone completed pivotal study and Intranasal Epinephrine (phase 2) as well as a number of preclinical POC programs.

Contact:
Info@nasuspharma.com
Nasus Pharma Ltd. Israel
Tel: +972547707807
https://www.nasuspharma.com

PDF

Nasus Pharma Announces Positive Clinical Results of Recent Phase 2 Study With FMXIN002 Intranasal Epinephrine

sitrus — Tue, 05 Dec 2023 13:00:00 +0000

Rapid and higher epinephrine absorption- for potentially quicker rescue of patients in anaphylactic shock

Tel Aviv, Israel December 5 TH 2023– Nasus Pharma Ltd a clinical-stage biopharmaceutical company focused on developing needle-free, powder-based Intranasal (PBI) product portfolio, to address acute medical conditions announced the positive results from its latest clinical study of intranasal powder-based Epinephrine.

Nasus Pharma recently completed an additional phase 2 study (NP-006-Epinephrine) confirming the superiority and safety of its lead FMXIN002 Intranasal Epinephrine product. FMXIN002 is an investigational intranasal epinephrine powder spray device that is noninvasive, needle-free, user-friendly and reliable and could provide timely effective rescue for severe potentially life-threatening allergic reactions to food, medications and insect bites. The recent clinical study explored the safety and efficacy of FMXIN002 in its intended clinical dose and provided additional compelling evidence to the robustness of Nasus Pharma intranasal powder technology already tested in a prior pilot study ( Tal, et al. The Journal of Allergy and Clinical Immunology: In Practice 11.10 (2023).). Importantly the pharmacokinetics of the powder-based intranasal epinephrine were able to abate multiple concerns recently raised within the medical community as to the adequacy of other albeit solution-based epinephrine products in development with regards to the protection in the immediate period following anaphylactic shock development: FMXIN002 demonstrated clear and meaningful advantage both in the pharmacokinetic profile of the first 20 minutes and in the number of patients reaching drug plasma clinical threshold of Epinephrine.

“The results of NP-006-Epinephrine study are further confirmation of the advantages of our powder intranasal epinephrine in covering the immediate period of anaphylactic shock- both in creating higher levels of Epinephrine in the blood quicker and in creating clinically meaningful epinephrine levels in significantly more patients. FMXIMIN002 can potentially be more effective rescue for the emergency treatment of life-threatening allergic reactions by providing a compact easy-to-use, needle-free device and quicker absorption of Epinephrine”. Said Dr. Dalia Megiddo, Nasus Pharma CEO.

NP-006-Epinephrine study was an open-label, ascending dose, three-period, threetreatment, comparative bioavailability study designed to compare the PK profile ascending doses ( 3.6 and 4mg) of FMXIN002 nasal spray with the current standard of care- an intramuscular epinephrine autoinjector. (EpiPen®, Mylan)

Twelve (12) healthy volunteers received 0.3 mg IM epinephrine via an autoinjector or FMXIN002 and 3.6 mg and 4.0 mg intranasally in weekly intervals. The results demonstrate that the exposure (AUC0-t) and maximum plasma level (Cmax) of both FMXIN002 dosages were comparable to that of 0.3 mg IM injection of epinephrine however a meaningful advantage of intranasal administration was demonstrated at all timepoints up to 30 minutes both in the plasma drug levels and in the number of patients reaching clinical threshold of the drug in the plasma . The exposure at first 4 minutes was significantly higher after FMXIN002 4.0 mg nasal spray compared to EpiPen (AUC0- 4). Epinephrine mean plasma levels after 4.0 mg Intranasal at 4 minutes were 5 times higher compared to Epinephrine (27.4 hpg/ml vs 5.8 hpg/ml) (p-0.0377) . Epinephrine plasma levels after 4.0 mg Intranasal at 10 minutes were 2.3 times higher compared to Epinephrine (64.0hpg/ml vs 27.4 hpg/ml) and 160% higher at 20 minutes (111.4 hpg/ml vs 71 hpg/ml). Six minutes after dosing FMXIN002 4.0mg nasal spray, 91% of the subjects reached the clinical threshold of 100pg/m plasma epinephrine, while only 55% achieved this threshold after EpiPen administration. The level of 100 pg/mL plasma epinephrine is considered to be the clinical threshold where pharmacodynamic responses begins to occur when treating anaphylaxis. These findings indicate that FMXIN002 can provide an unprecedented quick rescue with a non-invasive easy to use device for life threatening allergic reactions.

The treatment was well tolerated. There were no significant side effects and no significant changes in physiological parameters. The pharmacodynamic response was comparable to that of EpiPen.

Prof. Yoseph Caraco, the principal investigator at Hadassah medical center added:
“In cases of severe life-threatening allergic reaction, the therapeutic time window is very short and immediate rescue with epinephrine is critically required. To ensure immediate response the pharmacokinetics /pharmacodynamics of epinephrine rescue are extremely important. Failure to administer epinephrine promptly has been identified as the most important factor contributing to death from anaphylaxis. Parents and care givers are often hesitant to give injections. Teenagers are averse to carry the bulky two injection package with them at all times and are sadly over-represented in fatality cases. A pocket-size user-friendly nasal inhaler could potentially be the perfect solution for rescue therapy of life-threatening allergic reactions. In addition, the significantly shorter time to therapeutic blood levels and the higher drug exposure in the critical first half an hour imply that FMXIN002 could potentially change the fatality risk associated with anaphylaxis

Udi Gilboa, Executive Chairman of the Board added:
“We are extremely encouraged by the data generated by the company up-until today including in this dose-response Phase II trial. The commercial potential of our Powder-Based Epinephrine product and its potential to become the fastest-acting simple-to-administer, needle-free nasal spray, provides patients and caregivers with the most promising alternative for this growing Type I allergic reaction market.

The safety and fastest-response profiles of our needle-free product combined with the stability of our powder-based platform also provides payers with significant potential to expand the usage of epinephrine for severe allergic reactions.

This phase 2 study indicates that powder-based intranasal epinephrine can offer significant clinical advantages, as compared to the currently-available intramuscular route of drug administration and other solution-based intranasal epinephrine programs in development. Powder-based products are also known to have better stability, as compared to the solution-based products. Yet an additional advantage for powderbased formulation of epinephrine , a drug that undergoes rapid degradation in the currently-available short shelf-life liquid dosage forms.”

About FMXIN002
FMXIN002 is a powder formulation of epinephrine nasal spray developed by Nasus Pharma based on its unique intranasal powder proprietary technology. The company believes that the FMXIN002 may enable people to deliver epinephrine in emergency situations easily, rapidly, and with less hesitation, at the onset of an allergic reaction, as compared to currently available epinephrine auto-injectors. FMXIN002 uses APTAR Nasal Unidose Powder device – an intuitive and easy-to-use device with 360° functionality and precise one-dose nasal drug delivery.

About Nasus Pharma
Based on its unique microsphere technology, Nasus Pharma is developing a number of intranasal powder products aimed at assisting patients in several acute emergency situations such as opioid overdose and anaphylactic shock.

Contact:
Info@nasuspharma.com
Nasus Pharma Ltd. Israel
Tel: +972547707807
https://www.nasuspharma.com

PDF

Nasus Pharma Announces Publication Of Its Positive Clinical Results With FMXIN002 Intranasal Powder Epinephrine Spray In The Journal Of Allergy And Clinical Immunology In Practice

sitrus — Mon, 30 Oct 2023 08:43:42 +0000

CLICK HERE

Nasus pharma presented clinical results at Fourth Annual – ASPN Conference, July 14-17, Miami Beach

sitrus — Thu, 28 Jul 2022 08:23:24 +0000

CLICK HERE

ASPN Annual Conference July 14-17, 2022

Nasus Pharma presented clinical results of intranasal epinephrine in EAACI, July 2022, Prague

sitrus — Thu, 28 Jul 2022 08:18:34 +0000

CLICK HERE

https://www.eaaci.org/eaaci-congresses/eaaci-2022

Nasus Pharma announces publication of its pivotal study comparing its FMXIN001 powder nasal Naloxone to Narcan®

sitrus — Tue, 12 Apr 2022 07:02:25 +0000

CLICK HERE

Nasus Pharma Announces Positive Results from a Pilot Clinical Study of FMXIN002 Intranasal Powder Epinephrine Spray in

sitrus — Wed, 23 Jun 2021 13:54:16 +0000

Results demonstrate rapid epinephrine absorption- for potentially quicker rescue of
patients in anaphylactic shock

Tel Aviv Israel June 23 2021– Nasus Pharma Ltd a clinical-stage biopharmaceutical company focused on developing needle-free, powder-based Intranasal (PBI) specialized product portfolio, to address acute medical conditions announced positive results from a pilot trial of intranasal powder-based Epinephrine.

FMXIN002 is an investigational intranasal epinephrine powder spray device that is noninvasive, user-friendly and reliable and could provide timely effective rescue for severe potentially life-threatening allergic reactions to food, medications and insect bites. The pilot study is the first human study for powder Epinephrine and provides additional compelling evidence to the robustness of Nasus Pharma intranasal powder technology in addition to the recently published results of its intranasal Naloxone pivotal study.

“The results of the study with FMXIN002 powder intranasal Epinephrine show that it can provide a safer and more effective rescue for the emergency treatment of life- threatening allergic reactions by providing an easy-to-use device and quicker absorption of Epinephrine”. Said Dr. Dalia Megiddo. Nasus Pharma CEO.

The FMXIN002 pilot study was an open-label, ascending single dose, two-period, three- treatment, comparative bioavailability study designed to compare the PK profile of FMXIN002 with the current standard of care- an intramuscular epinephrine autoinjector. (EpiPen® , Mylan )

Twelve (12) volunteers with known seasonal allergies received three-sequenced treatment with either 0.3 mg IM epinephrine via an autoinjector or FMXIN002 in dosages of 1.6 and 3.2 mg. Each intranasal dosage was tested under normal conditions and under nasal allergen challenge in which nasal congestion was created to simulate the congestion of the nose in anaphylaxis. All in all, five treatments were given in a cross-over design to compare the PK/PD response to epinephrine delivered by FMXIN002 or injection with and without a nasal allergen challenge. The results demonstrate that the exposure (AUC0-t) and maximum plasma level (Cmax) of a 3.2 mg FMXIN002 dose was comparable to a 0.3 mg IM injection of epinephrine under normal nasal conditions. The time to maximum plasma level (tmax) and time to 100 pg/mL of a 3.2 mg FMXIM002 dose was significantly faster than IM injection. Time to 100 pg/mL was 10.2 minutes under normal conditions and 1.2 minutes under allergenic challenge that represents the real-life conditions of the nose in severe allergic reaction for FMXIN002 . T max for IM injection was 19.8 minutes. The time to 100 pg/mL is considered to be the clinical threshold where pharmacodynamic responses begin to occur.

FMXIN002 showed significantly superior PK profile especially during the first 30 minutes in a simulation of the real-life nasal congestions that occurs in severe allergic reactions: Cmax was double, compared to IM autoinjector (1110 vs. 551). AUC (0-8h ) was 56% higher (672 vs. 431) and Tmax was significantly shorter (2.0 min vs. 19.8 min) .

These finding combined with the significantly shorter time to reach the therapeutic clinical threshold of 100 pg/mL indicate that FMXIN002 can provides an unprecedented quick rescue with a non-invasive easy to use device for life threatening allergic reactions.

The treatment was well tolerated with no significant side effects and there were no excess changes physiological parameters.

Dr. Dalia Megiddo, Nasus Pharma CEO, said:
“In cases of severe life-threatening allergic reaction the therapeutic time window is very short and immediate rescue with Epinephrine is required. Therefore, the pharmacokinetics /pharmacodynamics of epinephrine rescue are extremely important for this immediate period. Failure to administer epinephrine promptly has been identified as the most important factor contributing to death in patients with allergies. Parents and care givers are often reluctant to give injections. A user-friendly simple nasal inhaler could make the much- needed rescue therapy be given in time. This, in addition to the significantly shorter time to therapeutic blood levels and higher dose in the relevant first half an hour FMXIN002 could change dramatically the risks associated with severe allergy and anaphylaxis”.

Udi Gilboa Nasus Pharma active chairman of Nasus board added:
It is well established that powder nasal drugs enjoy better bioavailability, quicker absorption and better stability compared to fluid nasal formulations. Nasus Pharma’s robust intranasal powder technology is proven again to deliver significantly quicker higher doses of rescue therapy in cases of medical emergencies where immediate therapy is needed. As with our Naloxone program now heading towards NDA, Nasus Pharm will continue to move forward with its development programs in collaboration with the regulatory authorities and with its pre-commercialization efforts with all stake-holders.

Prof. David Stepensky, Department of Clinical Biochemistry and Pharmacology, Faculty of Health Sciences, Ben-Gurion University of the Negev, Israel

Timely administration of epinephrine in cases of severe allergy and anaphylaxis is imperative in these life-threatening situations. The findings of this pilot study indicate that powder-based intranasal epinephrine can offer significant clinical advantages, as compared to the currently-available intramuscular route of drug administration. Powder-based products are also known to have better stability, as compared to the solution-based products. This could offer an additional advantage for powder-based

formulation of adrenaline, a drug that undergoes rapid degradation in the currently- available short shelf-life liquid dosage forms.

About FMXIN002

FMXIN002 is an powder formulation of epinephrine nasal spray developed by Nasus Pharma based on its unique intranasal powder proprietary technology. The company believes that the FMXIN002 may enable people to deliver epinephrine in emergency situations easily, rapidly, and with less hesitation, at the onset of an allergic reaction, as compared to currently available epinephrine auto-injectors. FMXIN002 uses APTAR Nasal Unidose Powder device – an intuitive and easy-to-use device with 360° functionality and precise one-dose nasal drug delivery.

Anaphylaxis is a severe, life-threatening allergic reaction with a sudden onset that can occur within a few minutes —and unless treated promptly could be fatal. Some 5 million people in the United States are at risk of having an anaphylaxis reaction. Over 200,000 emergency room visits due to severe reactions from food allergies are reported annually.

About Nasus Pharma

Based on its unique microsphere technology, Nasus Pharma is developing a number of intranasal powder products aimed at assisting patients in several acute emergency situations such as opioid overdose and anaphylactic shock. Intranasal administration is most suitable for those situations in which rapid drug delivery is required and offers multiple advantages such as rapid drug delivery, ease of use, non-invasiveness, and safety. Nasus portfolio comprises a number of programs:

Intranasal Naloxone completed pivotal study and Intranasal Epinephrine (phase 2) as well as a number of preclinical POC programs.

Contact:
Info@nasuspharma.com
Nasus Pharma Ltd. Israel
Tel: 972547707807
https://www.nasuspharma.com

Nasus Pharma announces positive Results in Naloxone Pivotal Trial.

sitrus — Tue, 13 Apr 2021 09:43:58 +0000

Nasus Pharma Announces Positive Results in Pivotal Trial of FMXIN001 Naloxone Powder-Based Nasal Spray for the Treatment of opioid overdose

• Significantly higher rapid absorption of Naloxone – may be critical to rescue of over-dose victims.

• Excellent safety profile.

• NDA submission planned for later this year.

Tel Aviv Israel April 13 2021 — Nasus Pharma Ltd a clinical-stage biopharmaceutical company focused on developing needle-free, powder-based Intranasal ( PBI ) specialized product portfolio, to address acute medical conditions & public health threats announced positive results from a pivotal trial of intranasal powder based Naloxone.

The results of this single-dose, bioequivalence study of FMXIN001001 4 mg microspheres powder and Narcan® 4 mg/0.1 ml nasal spray showed that FMXIN001- Nasus Pharma powder-based Naloxone was absorbed significantly faster into the blood. Most notably in the first minutes and up to one hour FMXIN001 created significantly higher blood levels of Naloxone during the critical time for life-saving treatment of opioid overdose:

Area Under Curve ( AUC) after nasal inhalation of FMXIN001 in the first 4 minutes was 163% compared to solution based Narcan® ( p=0.005), 125% after 10 minutes ( p=0.047), and AUC between 10-30 minutes was 113% compared to Narcan® ( p=0.01). Cmax was 113% ( p=0.003). 42 health volunteers participated in the study. Side effects were minor and self-resolving representing an excellent safety profile.

The immediate time frame for treating victims of opioid overdose is extremely short and getting Naloxone quickly into the blood stream could have a critical influence on patient’s condition and mortality risk. The rapid rise in Naloxone levels in the blood may be advantageous for reversing respiratory depression in opioid overdose. The superior absorption profile and the superb safety can position FMXIN001 as the leading overdose reversing drug.

Because Naloxone is a competitive opiate receptor antagonist, its efficacy in reversing overdose depends on both the quantity of opioids used and their relative affinities for opiate receptors. This information is rarely available to first responders (or bystanders) attempting to resuscitate a suspected overdose therefore immediate and effective treatment is critical.

Over 81,000 drug overdose deaths occurred in the United States in the 12 months ending in May 2020, the highest number of overdose deaths ever recorded in a 12-month period, according to recent provisional data from the Centers for Disease Control and Prevention (CDC)ⁱ. This is especially relevant because of the dramatic rise in the abuse of high-potency opioids such as fentanyl that requires higher concentrations of Naloxone to treat overdose. Indeed, field studies show that about a third of opioid overdose victim will need a second dose within the first few minutes and about 16% will need a third dose.

“The results announced today demonstrate the impressive advantages of Nasus Pharma powder based intranasal technology combined with the tested reliability of Aptar Pharma’s Unidose Powder device,” said Dr. Dalia Megiddo , Nasus Pharma co-founder and CEO. “The advantages of intranasal administration of Naloxone in the treatment of opioid overdose are well established, and absorption of our powder-based Naloxone to the blood in the first few minutes could signify higher lifesaving effect especially in patients with serious respiratory depression. We are focused on our NDA submission later this year with an objective to commercialized FMXIN001 in 2022.”

Udi Gilboa, Nasus Executive Chairman and Nasus Pharma co-founder said, “The current COVID pandemic masked the ongoing pandemic of opioid overdose in the public eye, despite the fact that it contributed to the alarmingly increased use of high potency opioids and the rising mortality from overdose. We believe FMXIN001 with its very well differentiated IP can be a more effective way to deal with this critical public-health threat and to better treat victims of opioids overdose non-invasively and safely. We are working toward commercial readiness during 2022 ”.

About FMXIN001

Nasus Pharma IP protected powder based composition for intranasal delivery is comprised of uniform spherical API’s and a carrier approved for inhalations. The active compound’s shape, size, and morphology in combination with a device provides rapid and precise delivery of the drug to the blood stream. FMXIN001 is a combination drug device using Aptar Pharma’s Unidose Powder device. Each single use device contains 4 mg of Naloxone powder. More details can be found on the Nasus Pharma’s website.

About Nasus Pharma

Intranasal administration is most suitable for those situations in which rapid drug delivery is required and offers multiple advantages such as rapid drug delivery, ease of use, non-invasiveness, and safety. Nasus portfolio comprises a number of programs: Intranasal Naloxone completed pivotal study and Intranasal Epinephrine (phase 2) as well as a number of preclinical POC programs.

Contact:
Info@nasuspharma.com
Nasus Pharma Ltd. Israel
Tel: 972547707807
https://www.nasuspharma.com ⁱhttps://emergency.cdc.gov/han/2020/han00438.asp