FDA Offers Draft Guidance on Generic Versions of Opioid Overdose Nasal Spray

Posted 24 April 2017 By Zachary Brennan

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As the opioid epidemic continues to spread, the US Food and Drug Administration (FDA) is looking to alleviate some of that pain by offering new draft guidance to generic drug companies looking to develop generic versions of the nasal spray that can reverse opioid overdoses.

The draft guidance is meant to help companies understand what studies need to be conducted to win approval for generics of Adapt Pharma’s Narcan nasal spray, also known as naloxone hydrochloride nasal spray.

Narcan nasal spray was initially approved in 2015, and FDA notes that in November 2016, Adapt submitted a citizen petition (a tool sometimes used to delay the entry of generic drugs) requesting that FDA refrain from approving any abbreviated new drug application (ANDA) referencing Narcan nasal spray unless certain conditions are satisfied, including conditions related to demonstrating bioequivalence.

The petition comes as the cost of the nasal spray and other forms of naloxone continue to rise. But Adapt says it has never raised its version of the Narcan nasal spray, which it says the 4mg version costs $125 for two doses. 

"The costs have not climbed - Adapt Pharma has never taken a price increase on Narcan Nasal Spray 4mg. The cost of Narcan Nasal Spray is discounted 40% to $37.50 per dose to all public interest entities (EMS, Law Enforcement, Harm Reduction, etc.) Adapt Pharma publicly lists the price Narcan Nasal Spray and insurance coverage at: https://www.narcan.com/affordability 94% of insured lives in the US have coverage for Narcan Nasal Spray. According to IMS Health, nearly three quarters (74%) of prescriptions for Narcan Nasal Spray have a co-pay of $10 or less. For those paying cash, Adapt Pharma has partnered with retail pharmacies to reduce out of pocket costs," Thom Dudy, executive director of communications at Adapt told Focus.

But FDA says this draft guidance is outside that citizen petition, which it will respond to separately. And the draft should begin the process of developing and bringing to market less expensive versions of naloxone nasal spray.

Draft Details

The three-page draft offers two options: In vivo or In vitro studies, revealing the specifics and differences in each.

For guidance on how to develop a drug-device generic combo product that’s suitable to win approval, FDA points to its guidance entitled, “Comparative Analyses and Related Comparative Use Human Factors Studies for a Drug-Device Combination Product Submitted in an ANDA (January 2017),” which provides the agency’s current thinking on the identification and assessment of any differences in the design of the user interface for a proposed generic drug-device combination product when compared to its RLD [reference listed drug].”

FDA also clarifies that early in product development and/or prior to an ANDA submission, applicants should submit to the Office of Generic Drugs, via controlled correspondence and/or a pre-ANDA meeting request, “the results of the comparative analyses (e.g., comparative labeling analysis, comparative task analyses, physical comparison of the delivery device constituent part), including an overall assessment of any identified differences between the user interface of the T product when compared to the R product, as described in the guidance referenced above.”

Draft Guidance on Naloxone Hydrochloride

Story updated 4/27 with comment from Adapt.

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Categories: Combination products, Drugs, Government affairs, Regulatory strategy, Regulatory intelligence, News, US, FDA

Tags: Narcan, opioid overdose, Narcan nasal spray, naloxone

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