Shares of Elite Pharmaceuticals Inc. (OTCMKTS:ELTP) traded higher in Monday’s trading session as investors reacted to topline results from a pivotal bioequivalence fed study of SequestOx.
Topline SequestOx Results
Elite Pharmaceuticals Inc. (OTCMKTS:ELTP) is a specialty pharmaceutical company focused on the development of proprietary pharmacological abuse deterrent opioid products. The pharmaceutical company has eight commercial products on sale, in addition to approved products pending manufacturing. The company also owns generic and OTC products licensed to TAGI Pharma and Valeant Pharmaceuticals International.
Topline results for SequestOx affirm the company’s proprietary abuse deterrent technology. SequestOx is Elite Pharmaceuticals Inc. (OTCMKTS:ELTP) investigational product for the management of moderate to severe acute pain. The bioequivalence study carried on the opioid was a pivotal open-label, randomized clinical study evaluating the bioavailability of the modified formulation to a comparator under fed conditions.
Compared to Roxicodone the candidate drug achieved a Tmax of 4.6hr with a range of 0.5 hr. to 12hr. Elite will not proceed with the rest of clinical trials on the drug, pending FDA clarity on the next steps needed for the release of SequestOx.
“We were hoping for better and more decisive results for the reformulated immediate release version of SequestOx. 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,” said CEO, Nasrat Hakim.
Elite Pharmaceuticals Inc. (OTCMKTS:ELTP) is on target on its pipeline objectives for 2017 after the top line SequestOx results. The Company plans to file one ANDA application this quarter and an additional two in the fourth quarter.
ANDA filling already made, target markets where branded products generic equivalents generate annual sales of $4 billion according to IMS health data. The company is in the process of making an application for a generic version of OxyContin that generated sales of $2.5 billion in 2015.
SequestOx topline results build on positive results for an undisclosed product that Elite Pharmaceuticals Inc. (OTCMKTS:ELTP) is developing in partnership with SunGen Pharma. The generic product under development is bioequivalent to a branded product in both fasted and fed studies. If approved the drug will expand the company’s footprint into a generic market worth $600 a million in revenues a year.