Intranasal Naloxone (NS -001)

Medical need

in 2017 ~72000 overdose death in the USA~42000 from opioids.

Market structure

current treatment is Naloxone ( IM or IV ) and recently intranasal.  Narcan first solution-based intranasal therapy approved in 2017 first generic (Teva) approved 2019

Regulatory requirements

bioequivalence study –”equal or better”

“Eyeing $1B in annual sales, Emergent Bio Solutions to buys Narcan maker Adapt for $735M  (9/2018)”

nasusphrma taffix

Development plan

Excellent data of POC (preformed Q 3 2019)
End of Phase II meeting Q 2 2020)
Phase III (Registration) Q 2 2020
NDA submission Q 4 2020
nasusphrma taffix
nasusphrma taffix

NS – 001 VS Narcan

The peak systemic exposure was approximately​ |  1.6 fold higher;​

The partial AUC0-4 minutes was approximately​ | 7 fold higher;​

The partial AUC0-10 minutes was approximate​ |  4 fold higher;​

The partial AUC10-30 minutes was approximate​​ |  1.6 fold higher;​

The total systemic exposure was approximate​ |  1.26 fold higher;​

The median Tmax occurred approximately​​ |  5 minutes earlier;​

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