13 new drugs submitted for FDA approval in Oct

One of the interesting drugs that is submitted for FDA approval is called Vivitrol, for opioid addiction. Apparently there is a version out right now for alcohol addiction, but this other version will be for opioid addicition.

The following is from the manufacture website:
" Opioid dependence is a serious disease affecting approximately two million people in the U.S.(1) In addition to the use of heroin, an illegal opioid, opioid dependence includes the non-medical use of opioid analgesics approved by the U.S. Food and Drug Administration (FDA). We are developing VIVITROL® as a potential new treatment option for people who are dependent upon or abuse opioids.

New treatment paradigm: There are few approved medications available for treating opioid dependence and no approved long-acting antagonist therapies. If approved, VIVITROL would be the first and only non-narcotic, non-addictive, long-acting medication for the treatment of opioid dependence.

Pipeline progress: In November 2009, Alkermes announced positive preliminary results from a phase 3 clinical trial of VIVITROL for the treatment of opioid dependence. The six-month phase 3 study met its primary efficacy endpoint and data showed that patients treated once-monthly with VIVITROL demonstrated statistically significant higher rates of clean (opioid-free) urine screens, compared to patients treated with placebo. In April 2010, Alkermes submitted a supplemental New Drug Application (sNDA) for VIVITROL to the U.S. Food and Drug Administration (FDA) for approval as a treatment for opioid dependence.

VIVITROL is not currently approved for the treatment of opioid dependence. "
http://www.alkermes.com/our-products.aspx

Orginal website that lists the 13 new drugs submitted for approval is:
http://www.thestreet.com/story/10784106/7/13-drugs-facing-fda-approval-decisions.html

".....aspirins are perfectly legal, but if you take 13 of those muthafuckas that'll be your last headache...."
Katt Williams