Insys Therapeutics Inc. (fka INSYQ)

[terry hallinan]

I've been investing in and poking around biotech for longer than there was the handle "biotech" and never before have I seen a biotech just up and announce they are seeking approval of a drug without any of the little preliminaries - oh, like clinical trials fer instance.

Now I have.

It's not as if there aren't a world of clinical trials of buprenorphine ongoing and completed:

http://www.druglib.com/druginfo/buprenex/trials/

New trend? New allowance? No need for proprietary protection? ?????

Maybe Insys' patented delivery is enough.

Whatever, sounds great.

Buprenorphine was as much a proof-of-concept vehicle for the National Drug Abuse Treatment Clinical Trials Network (CTN) as the CTN was a platform for demonstrating the clinical utility and practicability of buprenorphine. That is, buprenorphine gave the CTN its first line of inquiry, providing the newly established entity with substantial credibility. Buprenorphine is a mu-opioid partial agonist approved by the FDA in 2002 for the treatment of opioid dependence, and it appears to have less potential for psychological and/or physical dependence than traditional full-agonist opioids like methadone (Jasinski et al., 1978). Although buprenorphine, as an opioid partial agonist at the mu-opioid receptor, produces typical opioid-associated subjective and physiological effects, these effects are less than those produced by full agonists such as morphine, and is effective in preventing the onset of the opioid-abstinence syndrome in opioid-dependent individuals (McCance-Katz, 2004).

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2853172/

Best, Terry