NORTHVALE, N.J., Jan. 23, 2017 (GLOBE NEWSWIRE) -- Elite Pharmaceuticals, Inc. ("Elite" or the “Company")
(OTCBB:ELTP) today reported the Company received official minutes from its December 21, 2016 end-of-review meeting with the U.S.
Food and Drug Administration (the “FDA”) for the New Drug Application (the “NDA”) for SequestOx™ (oxycodone hydrochloride and
sequestered naltrexone hydrochloride). The meeting minutes support a plan to address the issues cited by the FDA in the July
14th Complete Response Letter by modifying the SequestOxTM formulation. Elite will proceed immediately
to complete in vitro and in vivo bridging studies required and expects to resubmit the SequestOxTM application later
this year. The in vivo studies include bioequivalence and bioavailability fed and fasted studies comparing the modified formulation
to the original formulation.
SequestOx™ is Elite’s investigational abuse-deterrent opioid candidate for the management of moderate to severe acute pain where
the use of an opioid analgesic is appropriate.
“We are very pleased that the meeting discussions with the FDA provide a clear path forward for SequestOx™,” said Nasrat Hakim,
President and CEO of Elite. “Based on the guidance received from the agency, we plan to initiate the bridging studies immediately
and are expecting to resubmit our NDA this year.”
About Elite Pharmaceuticals,
Inc.
Elite Pharmaceuticals, Inc. is a specialty pharmaceutical company which is developing a pipeline of proprietary pharmacological
abuse-deterrent opioid products as well as niche generic products. Elite specializes in oral sustained and controlled release
drug products which have high barriers to entry. Elite owns generic and OTC products which have been licensed to TAGI Pharma,
Epic Pharma and Valeant Pharmaceuticals International. Elite currently has eight commercial products being sold, additional
approved products pending manufacturing site transfer and the NDA for SequestOx™, for which it received the CRL from the FDA.
Elite’s lead pipeline products include abuse-deterrent opioids which utilize the Company’s patented proprietary technology and a
once-daily opioid. These products include sustained release oral formulations of opioids for the treatment of chronic pain.
These formulations are intended to address two major limitations of existing oral opioids: the provision of consistent relief of
baseline pain levels and deterrence of potential opioid abuse. Elite also provides contract manufacturing for Ascend
Laboratories (a subsidiary of Alkem Laboratories Ltd.). Elite operates a GMP and DEA registered facility for research, development,
and manufacturing located in Northvale, NJ. Learn more at www.elitepharma.com.
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation
Reform Act of 1995. Including those related to the effects, if any, on future results, performance or other expectations that may
have some correlation to the subject matter of this press release, readers are cautioned that such forward-looking statements
involve risks and uncertainties including, without limitation, Elite’s ability to obtain FDA approval of the transfers of the ANDAs
or the timing of such approval processes, delays, uncertainties, inability to obtain necessary ingredients and other factors not
under the control of Elite, which may cause actual results, performance or achievements of Elite to be materially different from
the results, performance or other expectations that may be implied by these forward-looking statements. These forward-looking
statements may include statements regarding the expected timing of approval, if at all, of SequestOx™ by the FDA, the steps Elite
may take as a result of the CRL, and the actions the FDA require of Elite in order to obtain approval of the NDA. These
forward-looking statements are not guarantees of future action or performance. These risks and other factors, including, without
limitation, Elite’s ability to obtain sufficient funding under the LPC Agreement or from other sources, the timing or results of
pending and future clinical trials, regulatory reviews and approvals by the Food and Drug Administration and other regulatory
authorities, intellectual property protections and defenses, and the Elite’s ability to operate as a going concern, are discussed
in Elite's filings with the Securities and Exchange Commission, including its reports on forms 10-K, 10-Q and 8-K. Elite is under
no obligation to update or alter its forward-looking statements, whether as a result of new information, future events or
otherwise.
Contact: Elite Pharmaceuticals, Inc. Dianne Will, Investor Relations 518-398-6222 Dianne@elitepharma.com
