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Elite reports topline results from bioequivalence fed study for SequestOx

Published 10 July 2017

Elite Pharmaceuticals has reported topline results from a pivotal bioequivalence fed study for SequestOx.

The mean Tmax of SequestOx was 4.6 hr with a range of 0.5 hr to 12 hr and the mean Tmax of the comparator, Roxicodone®, was 3.4 hr with a range of 0.5 hr to 12 hr.   A key objective for the study was to determine if the reformulated SequestOx had a similar ax to the comparator when taken with a high fat meal. 

Elite will pause, not proceed with the rest of the clinical trials, and seek clarity from FDA before deciding on the next steps for immediate release SequestOx. Elite will continue to pursue extended release products with its proprietary abuse deterrent technology

Elite’s pipeline objectives for 2017 remain on-target as Elite is planning the submission of one ANDA filing this current quarter and an additional two ANDA filings in the fourth quarter.  Elite will update you on the progress of these targets in the next investor call. 

Elite’s ANDA filings already submitted to the FDA combined with the three ANDAs targeted for submission later this year have total U.S. sales, for the branded products and their generic equivalents, of $4 billion according to IMS Health Data. 

Elite’s pipeline will continue to include abuse deterrent products.  The next abuse-deterrent product expected to be filed will be a generic version of OxyContin for which IMS reported approximately $2.5 billion in revenue in 2015. 

“We were hoping for better and more decisive results for the reformulated immediate release version of SequestOx”, said Nasrat Hakim, President and CEO of Elite Pharmaceuticals. “We remain positive with respect to Elite’s abuse-deterrent and generic pipeline. We will see the results of our hard work over the next six to twelve months.”

SequestOx is Elite’s investigational immediate-release oxycodone with sequestered naltrexone abuse-deterrent opioid product for the management of moderate to severe acute pain where the use of an opioid analgesic is appropriate.

The study was a pivotal, open-label, randomized, single-dose, three-way, crossover study to evaluate the relative bioavailability and bioequivalence of the modified formulation of SequestOx to the original formulation of SequestOx and to a comparator product under fed conditions. The study also evaluated the ax of a reformulated SequestOx compared to the original SequestOx formulation and a comparator product under fed conditions.

Source: Company Press Release