Elite Pharmaceuticals Reports Positive Topline Results from SequestOx™ Pilot Study
PRESS RELEASE GlobeNewswire
Jan. 30, 2018, 02:35 PM
NORTHVALE, N.J., Jan. 30, 2018 (GLOBE NEWSWIRE) -- Elite Pharmaceuticals, Inc. ("Elite" or the “Company") (OTCBB:ELTP) today reported positive topline results from a pilot study conducted for SequestOx™, Elite’s immediate release Oxycodone Hydrochloride product that incorporates its proprietary abuse-deterrent technology. An objective of the study was to assess whether the reformulated SequestOx could achieve a Tmax (the mean or median time to the maximum drug concentration in subjects) comparable to the reference drug, Roxicodone, when dosed with the standard high fat meal specified by the FDA. As opposed to the earlier formulation, based on these pilot results, the modified SequestOx™ is expected to achieve bioequivalence with a Tmax range equivalent to the reference product when conducted in a pivotal trial under fed conditions. Elite intends to review with the FDA the study results and discuss the pharmacokinetic study requirements for a re-submission of the NDA.
IMS reports approximately $400 million annually in revenue for the immediate release oxycodone generic market. There is currently one other approved, but not yet commercialized, abuse-deterrent product and many non-abuse deterrent generic products in this market. Immediate release oxycodone is one of the most highly abused opioids in the U.S.
SequestOx is Elite’s investigational abuse-deterrent immediate-release oxycodone product with sequestered naltrexone for the management of moderate to severe acute pain where the use of an opioid analgesic is appropriate. The study was a Phase 1 pilot, randomized, single-dose, single period, pharmacokinetic study in healthy male and female volunteers in the fed state. The test products included two formulation modifications of SequestOx, a unique abuse-deterrent formulation without sequestered naltrexone, and a reference product. The following table summarizes the Tmax results for the pilot study.
Parameter Treatment N* median min max
Tmax Reference 12 2.25 1.28 5.00
Test-A 12 2.50 1.25 5.00
Test-B 11 3.00 1.00 4.00
Test-C 11 2.50 0.50 3.00
* N=number of subjects
“The reformulated SequestOx™ performed well in this pilot study and should provide a path forward for overcoming prior Tmax issues under fed conditions,” commented Nasrat Hakim, President and CEO of Elite Pharmaceuticals. “I’m excited about these outstanding results and look forward to reviewing them with the FDA.”
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