Buvaya Denied by FDA

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anonymous

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May 22, 2018 (GLOBE NEWSWIRE) -- INSYS Therapeutics, Inc. (INSY), a leader in the development, manufacture and commercialization of pharmaceutical cannabinoids and spray technology, confirmed today that an expert panel convened by the U.S. Food and Drug Administration (FDA) voted not to recommend approval of the company’s New Drug Application (NDA) for a buprenorphine sublingual spray as a treatment for moderate-to-severe acute pain.


This is a substantial blow to the company. Subsys and Syndros won’t keep this boat floating for too much longer. Better start looking for a way out if you haven’t already.
 






This is very bad news for the organization. The CBD candidate won’t be available (if approved) until mid to late 2019. Not sure Insys can stick around that long. This failure by senior leadership and R&D has put the company in a very vulnerable position.
 












anonymous said:
Why isnt the FDA on our side?
Click to expand...


Go read the articles that were released following regulatory’s meeting with the FDA. The outcome was 18-1 in favor of not recommending approval. The onset of action was less than desirable to treat acute pain, and the side effects were far greater with Buvaya when compared with current comparable therapies.
 












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