NORTHVALE, N.J., Feb. 17, 2015 (GLOBE NEWSWIRE) -- Elite Pharmaceuticals, Inc. ("Elite" or the "Company") (OTCQB:ELTP) announced guidance today regarding the Company's Phase III trial for ELI-200, an abuse deterrent opioid product. Elite has submitted a study protocol to the FDA and dosing for the study is expected to begin shortly after the FDA comments on the protocol are received by Elite. The Company anticipates that it will receive the FDA comments by mid-March and that dosing will take approximately eight weeks to complete.
The Phase III study is a multi-center, randomized, multiple-dose, double-blind, 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 150 patients. We anticipate filing the ELI-200 NDA in Q3 and therefore expect the NDA review by FDA to be completed by early 2016.
Two additional studies will also be completed to support product labeling. 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. Dosing of this study has been completed. The second 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. The dosing of the withdrawal study has been initiated. Results and reports for both studies are expected to be available prior to the completion of the Phase III study.
"We are pleased with the guidance we have received from the FDA and the clear regulatory pathway forward for ELI-200. Our filing date is expected to be in the third quarter of this year, and we are encouraged that the FDA review leading to approval is expected to be completed by early 2016," said Nasrat Hakim, President and CEO of Elite Pharmaceuticals. "In preparation for the launch of ELI-200, we are also expanding our manufacturing facility and adding capacity. ELI-200 is the first of our abuse-deterrent opioid pipeline of products under development utilizing our proprietary technology platform."
About Elite's Abuse Deterrent Technology
Elite's proprietary abuse deterrent technology 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 resistance 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 has eight commercial products currently being sold, several additional approved products pending manufacturing site transfer and an additional 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 has partnered with Epic Pharma for the manufacturing and distribution of eleven approved products pending manufacturing site transfer, with Hi-Tech Pharmacal to develop an intermediate for a generic product, 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.