- INSYS Therapeutics (NASDAQ:INSY) slips 5% premarket on light volume on the heels of the release of briefing documents for next Tuesday's Ad Com review for Buvaya.
- Per the FDA document (page 25): "In conclusion, the Applicant’s efficacy data demonstrate superiority of [Buvaya] over placebo for all doses tested, however time to onset of analgesia is later than is optimal for a drug intended to treat acute pain and the need for rescue analgesic was high. From a safety perspective, there is an unexpectedly high rate of nausea, vomiting and dizziness for [Buvaya]. And the Applicant showed in a comparative safety study that rates for [Buvaya] are markedly higher than rates for other opioids (morphine and oxycodone) used in similar acute pain settings. The totality of data submitted by the Applicant does not support the use of this product in an acute pain setting, based on both efficacy and safety findings."
- Previously: Ad Com review next week for INSYS Therapeutics' pain med buprenorphine sublingual spray (May 18)
- Now read: TG Therapeutics: Assessing The Investment Prospects Of A Potential Big Winner
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