NORTHVALE, N.J., May 19, 2014 (GLOBE NEWSWIRE) -- Elite Pharmaceuticals, Inc. ("Elite" or the "Company") ("Elite") (OTCBB:ELTP) announced today the first dosing of a pivotal bioequivalence study in healthy volunteers for ELI-202, an undisclosed opioid abuse deterrent product, utilizing Elite's proprietary pharmacological abuse deterrent technology.
Two bioequivalence studies will be run together for ELI-202. The first study is a single-dose, open-label, three treatment, three-way crossover study in which 32 healthy adult subjects will receive treatment in a partially randomized sequence. The primary objective of this first study is to compare the bioavailability of the Company's abuse deterrent product to that from the reference listed drug under fasted conditions. The secondary objectives are to compare the bioavailability of the Company's abuse deterrent product under fasted and fed conditions, and to evaluate the safety and tolerability of the Company's product. The second study is a single-dose, open-label, two treatment, two-way crossover study in which 32 healthy adult subjects will receive randomized treatment. The primary objective of this second study is to compare the bioavailability of the Company's abuse deterrent product to that of the reference listed drug under fasted conditions and the secondary objective is to evaluate the safety and tolerability of the Company's product.
"Abuse of prescription narcotics is a serious problem in our society and we are pleased to be working with new approaches to help address this problem," said Nasrat Hakim, President and CEO of Elite. "I have described my vision for a range of abuse deterrent products that use Elite's proprietary pharmacological abuse deterrent technology and I am pleased to announce initiation of this pivotal study for ELI-202, one of several abuse deterrent products currently under development by Elite. Our plans include completing bioequivalency studies for a third abuse deterrent product and doing In Vitro Lab Abuse Studies and human abuse studies for the first product in 2014. I expect Elite to file an NDA for its first abuse deterrent product with the FDA by year's end."
Elite's development pipeline includes a range of opioid products utilizing Elite's proprietary abuse deterrent technology. Elite is currently working on five such abuse deterrent products. Elite completed a successful pilot study in December for a twice daily oxycodone product in which Elite's formulation demonstrated bioequivalence to a brand comparator product. A second abuse deterrent product, ELI-200, successfully was demonstrated to be bioequivalent to the brand comparator in a pivotal biostudy in January and now, a third abuse deterrent product, ELI-202, has entered a pivotal bioequivalence trials. A fourth product is expected to enter pivotal bioequivalence studies later this year. Additional human and laboratory abuse liability studies are also planned for these products, and Elite expects to file it first abuse deterrent product NDA by year's end.
The bioequivalence studies for these opioid abuse deterrent products are being conducted under the direction of Camargo Pharmaceutical Services.
About Section 505(b)(2)
The Company plans to file an NDA for this product based on the provisions of section 505(b)(2) of the U.S. Food, Drug & Cosmetic Act. Section 505(b)(2) allows the FDA to approve a drug on the basis of data in the scientific literature or data previously cited by the FDA as the basis for the approval of related drugs. This procedure makes it easier and potentially faster for drug developers to obtain approval of new formulations of drugs based, in part, on proprietary data of the developer of the original drug.
About Camargo Pharmaceutical Services
Camargo is a full-service drug development partner specializing in the 505(b)(2) process — an approach for developing products that offer differentiated benefits. Camargo is capable of managing every facet of the plan throughout the development continuum, from feasibility assessments, formulation and testing the drug product, to conducting preclinical and clinical studies, to final submission.
About Elite's Abuse Deterrent Technology
Elite's abuse deterrent products utilize the Company's proprietary pharmacological abuse deterrent technology. Elite's abuse deterrent technology is a multi-particulate capsule which contains an opioid agonist in addition to naltrexone, an opioid antagonist. Naltrexone is an opioid receptor 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, naltrexone, is designed to release. The absorption of the naltrexone is intended to block the euphoria by preferentially binding to same receptors in the brain as the opioid agonist and thereby reducing the incentive for abuse or misuse by recreational drug abusers.
About Elite Pharmaceuticals, Inc.
Elite Pharmaceuticals, Inc. develops oral sustained and controlled release products. Elite has seven commercial products currently being sold, eleven additional approved products pending manufacturing site transfer and two additional products under review pending approval by the FDA. Elite's lead pipeline products include abuse resistant opioids utilizing the Company's patented proprietary technology and include 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, 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.