Insys Therapeutics Inc. (fka INSYQ)

[terry hallinan]

INSYS Therapeutics Confirms Outcome of FDA Advisory Committee Meeting on Buprenorphine Sublingual Spray

PHOENIX, May 22, 2018 (GLOBE NEWSWIRE) -- INSYS Therapeutics, Inc. (NASDAQ: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.

https://tinyurl.com/yd6udr82

This looks like another case of the fine people at the FDA stomping on the guys wearing "KICK ME" signs on the back of their pants rather than decent proceedings.

Buprenorphine-Naloxone Film

Uses

This medication contains 2 medicines: buprenorphine and naloxone. It is used to treat opioid (narcotic) dependence/addiction. Buprenorphine belongs to a class of drugs called mixed opioid agonist-antagonists. Buprenorphine helps prevent withdrawal symptoms caused by stopping other opioids.

Naloxone is a narcotic antagonist that blocks the effect of opioids and can cause severe opioid withdrawal when injected. Withdrawal is less likely when naloxone is taken by mouth, dissolved under the tongue, or dissolved on the inside of the cheek. It is combined with buprenorphine to prevent abuse and misuse (injection) of this medication. This combination medication is used as part of a complete treatment program for drug abuse (such as compliance monitoring, counseling, behavioral contract, lifestyle changes).

https://tinyurl.com/https-www-webmd-com-drugs-2

No reason is given for the FDA rejecting an approved drug from INSY that would help ward off the the withdrawal symptoms from people trying to get off opioids.

The FDA doesn't want people getting off opoids? What?

Best, Terry