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.”
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