Elite Pharmaceuticals Inc (ELTP)

[Couch]

The FDA continuing to push for Abuse Deterrent Opioids.

FDA Plans To Finalize Guidance on Generic Abuse-Deterrent Opioids by End of Year

http://claad.org/fda-plans-finalize-guidance-generic-abuse-deterrent-opioids-end-year/

The U.S. Food & Drug Administration (FDA) expects to finalize guidance on the development of generic abuse-deterrent opioids (ADOs) by the end of 2017. However, the FDA says that further research is still needed to bring generic ADOs to the market.

Elite already working on filing a generic OxyContin by the end of the year.

Elite Pharmaceuticals Reports Positive Topline Results From A Pivotal Bioequivalence Study For A Generic OxyContin®

http://ir.elitepharma.com/profiles/investor/ResLibraryView.asp?ResLibraryID=82907&GoTopage=1&Category=2163&BzID=2258&t=2086&G=939

NORTHVALE, N.J, Jan. 17, 2017 (GLOBE NEWSWIRE) -- Elite Pharmaceuticals, Inc. ("Elite" or the "Company") (OTCBB:ELTP) today reported positive topline results from a pivotal bioequivalence fed study initiated in November 2016. The topline results indicate that Elite's generic product is bioequivalent to the branded product, OxyContin® (extended release Oxycodone Hydrochloride). A fasted study was previously conducted in September 2016, also with positive results.

The study was a single dose crossover comparative bioavailability study of Oxycodone HCl extended release in healthy volunteers under fed conditions. The Elite product is a generic formulation of the branded product, OxyContin®, with strengths of 10 mg, 15 mg, 20 mg, 30 mg, 40 mg, 60 mg and 80 mg, and incorporates physical abuse deterrent properties. IMS reported approximately $2.5 billion in revenue for OxyContin in 2015.

"Following our recent announcement regarding a successful FDA meeting for our immediate release Oxycodone HCl product SequestOx™, I am now very pleased to announce these positive topline study results for an abuse-deterrent twice-daily Oxycodone," said Nasrat Hakim, President and CEO of Elite Pharmaceuticals. "We intend to file an ANDA for this product later this year."