Insys pain med misses FDA panel support

Shares of Insys Therapeutics (INSY) are moving lower in pre-market trading after the FDA posted documents in advance of the joint meeting of AADPAC and DSaRM to discuss a new drug application from Insys for a sublingual spray formulation of buprenorphine with the proposed indication of the management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. The proposed tradename for this product is Buvaya. The briefing document prepared by the FDA staff states: “In conclusion, the Applicant’s efficacy data demonstrate superiority of BSS 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 BSS. And the Applicant showed in a comparative safety study that rates for BSS are markedly higher than rates for other opioids 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.” In pre-market trading, Insys shares are down 39c, or 5%, to $6.95.
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