NORTHVALE, N.J., April 21, 2015 (GLOBE NEWSWIRE) -- Elite Pharmaceuticals, Inc. ("Elite" or the "Company") (OTCQB:ELTP) today announced the launch of generic Hydroxyzine HCI 10 mg, 25 mg and 50 mg tablets through Epic Pharma LLC, a private pharmaceutical company located in Laurelton, NY. Hydroxyzine is indicated for symptomatic relief of anxiety and tension associated with certain disease states and management of pruritus due to certain allergic conditions. Annual U.S. sales for immediate release Hydroxyzine HCI 10 mg and 25 mg and 50 mg tablets are approximately $40 million for the twelve months ending June 30, 2014 according to IMS Health Data. Epic will manufacture, package and distribute the product under the Manufacturing and License Agreement previously signed between Epic and Elite.
Elite also announced that dosing was completed for two studies to support ELI-200 product labeling - the fed study and the withdrawal effects study. The first study is a Phase I, open-label, randomized, single-dose, three-way crossover study to compare the bioavailability of ELI-200 to the reference product under fed conditions in healthy volunteers. The second study, a safety study, is a randomized, double-blind, multiple-dose, parallel group study to evaluate the potential withdrawal effects following administration of ELI-200 versus the reference product in methadone-maintained opioid-dependent subjects. Final study results are not yet available.
A Phase III efficacy study is scheduled to begin dosing this quarter. This Phase III study is a multi-center, randomized, multiple-dose, blinded, placebo-controlled, parallel group, study to evaluate the efficacy and safety of abuse deterrent ELI-200 for the treatment of adults with moderate to severe pain following surgery. The study will enroll approximately 165 patients at five clinical sites and will begin once final FDA agreement is received for the protocol. We expect the study to begin in approximately 7 weeks and the dosing for the study to take approximately 8 weeks.
"Hydroxyzine is another generic product launched under our license to Epic," said Nasrat Hakim, President and CEO of Elite. "Elite continues to add to and grow our generic business. I am also pleased to have completed dosing for two of the ELI-200 studies requested by the FDA and we look forward to initiating the third study and reporting results in the coming months. We continue to plan for an ELI-200 filing this year."
About Elite's Abuse Deterrent Technology
Elite's proprietary abuse deterrent technology, ART™, is a multi-particulate capsule which contains an opioid agonist in addition to naltrexone, an opioid antagonist used primarily in the management of alcohol dependence and opioid dependence. When this product is taken as intended, the naltrexone is designed to pass through the body unreleased while the opioid agonist releases over time providing therapeutic pain relief for which it is prescribed. If the multi-particulate beads are crushed or dissolved, the opioid antagonist is designed to release. The absorption of the naltrexone is intended to block the euphoria by preferentially binding to the same receptors in the brain as the opioid agonist and thereby reducing the incentive for abuse or misuse by recreational drug abusers. Elite's pharmacological approach to abuse-deterrence can be applied to a wide range of opioids used today in pain management.
About Elite Pharmaceuticals, Inc.
Elite Pharmaceuticals, Inc. is a specialty pharmaceutical company developing a pipeline of proprietary pharmacological abuse-deterrent opioid products and niche generic products. Elite specializes in oral sustained and controlled release drug products with high barriers to entry. Elite owns generic and OTC products licensed to TAGI Pharma, Epic Pharma and Valeant Pharmaceuticals International with seven commercial products currently being sold, additional approved products pending manufacturing site transfer and a product under review pending approval by the FDA. Elite's lead pipeline products include abuse-deterrent opioids utilizing the Company's patented proprietary technology, and a once-daily opioid. They are sustained release oral formulations of opioids for the treatment of chronic pain, which address two of the limitations of existing oral opioids: the provision of consistent relief of baseline pain levels and deterrence of potential abuse. Elite also provides contract manufacturing for Ascend Laboratories (a subsidiary of Alkem Laboratories Ltd.), and a Hong Kong based company to develop a branded product for the United States market and its territories. Elite operates a GMP and DEA registered facility for research, development, and manufacturing located in Northvale, NJ.
This news 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, its ability to obtain FDA approval of the transfers of the ANDAs or the timing of such approval process, 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 risks and other factors, including, without limitation, the Company'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 Company'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 undertakes no obligation to update any forward-looking statements.
CONTACT: Elite Pharmaceuticals, Inc. Dianne Will, Investor Relations, 518-398-6222 Dianne@elitepharma.com
Source:Elite Pharmaceuticals, Inc.