NORTHVALE, N.J., March 31, 2008 (PRIME NEWSWIRE) -- Elite Pharmaceuticals, Inc. (AMEX:ELI), a leading drug delivery, specialty pharmaceutical company focused primarily on developing and commercializing proprietary abuse resistant, extended release pain compounds, today issued an update regarding its proprietary abuse resistant pain products.
Bernard J. Berk, Chairman and Chief Executive Officer of Elite, said, "Many experts have concluded that the abuse of prescription drugs for non-medical purposes has grown to epidemic proportions. Research efforts to mitigate opioid abuse and misuse have largely been unsuccessful. These conditions underscore the need for better, safer and more abuse resistant painkillers. Elite is preparing to commence Phase III clinical trials for ELI-216, the only once daily oxycodone containing naltrexone (an opioid antagonist) which provides a superior barrier to abuse compared to the other oxycodone formulations."
Commenting on information posted on the FDA's website regarding an FDA advisory committee meeting to review an abuse resistant form of oxycodone (OxyContin), Mr. Berk said, "Our pharmacological approach is differentiated from physical approaches of our competitors and may offer distinct advantages over their technologies which can not match the clinical results of our abuse resistant oxycodone formulation. While other companies' abuse resistant oxycodone utilizing physical approaches seem to be gaining momentum, we believe that our pharmacological approach is the most compelling abuse resistant technology and has the best chance for commercial success. To our knowledge, we are the only company that has shown, in clinical studies that our abuse resistant oxycodone will work as intended as an opioid antagonist."
Elite recently announced that it reached agreement with the FDA on the Special Protocol Assessment for its Phase III clinical trial for ELI-216. The SPA agreement is a significant milestone for Elite, providing a clearly defined pathway towards regulatory approval of the company's New Drug Application. The Phase III study is designed as a randomized withdrawal, placebo-controlled, double-blind trial which will be conducted at multiple centers in the U.S. The primary objective is to evaluate the safety and efficacy of ELI-216 controlled-release capsules administered once daily (QD) compared with placebo in the treatment of a pain associated with osteoarthritis. This study will aim to enroll approximately 150 patients in each treatment group in the double blind randomized withdrawal phase of the study (approximately 300 patients in total).
Elite's ELI-216 product is a controlled release product which contains oxycodone hydrochloride to treat moderate to severe chronic pain formulated in a manner to deter the diversion, unintended and illegal use of the product. The non-medical use of opioids by recreational users is a large and growing problem in the U.S. Elite's abuse resistance technology is based on incorporating an opioid antagonist with an agonist in the same formulation in such a way that when administered as an intact product, only the agonist will be absorbed in a sustained manner with essentially no absorption of the antagonist. When the product is physically damaged with the intent of abusing it, the antagonist is also released and absorbed thereby antagonizing the effect of the opioid.
Elite has submitted a Phase III plan for ELI-154 for a special protocol assessment (SPA) review to the FDA and is awaiting comments. The SPA for ELI-154 closely reflects that for ELI-216. The Company anticipates about 30 clinical sites will be involved in both of the Phase III trials of ELI-154.
The importance and very high level of public interest in abuse resistant opioid products is further supported by the recent notice listed in the Federal Register regarding an apparent filing of an OxyContin(r) product that is purportedly less easily defeated than the previous formulations. Elite believes its pharmacological approach provides a superior barrier to abuse when compared to physical approaches and Elite has the only once-a-day, pharmacological approach to abuse resistance. Elite continues to advance its pain products forward in its development program.
ELI-216
ELI-216 is a patent-pending, once-a-day extended release oxycodone product with sequestered naltrexone as an abuse resistant feature. Naltrexone is an opioid antagonist that is not released when the capsule is swallowed intact. However, if the product is tampered with to defeat the extended release technology, the pellets will release naltrexone and block any sense of euphoria that an abuser might be seeking. This sustained release product is intended for use in patients with moderate to severe chronic pain.
ELI-216 will shortly begin a multi-dose study in opioid dependent patients. Elite has previously completed a single dose study in healthy subjects and has shown that no measurable levels of naltrexone (with a level of quantification of 7.5 pcg/ml) are released. The multi-dose study is intended to confirm that upon reaching steady state, little or no naltrexone is released in chronic users of ELI-216.
In addition, a pharmacokinetic study will also be conducted examining the effect of various methods of crushing on the in vivo release of the antagonist, naltrexone. Elite will also conduct a food effect study to confirm there is not a material food effect on oxycodone release in this formulation. Elite previously completed a study with naltrexone beads and saw no food effect.
ELI-154
The Company also is advancing ELI-154, a once-a-daily oxycodone product that uses Elite's proprietary controlled release technology. Elite has submitted a Phase III protocol to the FDA for a Special Protocol Assessment for ELI-154 and we are waiting for their comments.
Company Update
Elite has also added resources in key areas as we progress to Phase III including the addition of Dr. Stuart Apfel as Chief Medical Officer and the engagement of an investment bank to supplement Elite's resources in completing a licensing transaction relating to its pain products. Elite has three patent applications filed on these products.
Mr. Berk concluded, "We continue to make significant progress with our two late stage lead pain products, ELI-216 and ELI-154, and are confident they will present a practical solution to the growing problem of opioid abuse."
About Elite Pharmaceuticals, Inc.
Elite Pharmaceuticals www.elitepharma.com is a specialty pharmaceutical company principally engaged in the development and manufacturing of oral controlled-release products. The Company's strategy includes developing generic versions of controlled release drug products with high barriers to entry and assisting partner companies in the life cycle management of products to improve off-patent drug products. Elite's technology is applicable to develop delayed, sustained or targeted release capsules or tablets. Elite has two products currently being sold commercially and a pipeline of seven drug products under development in the therapeutic areas that include pain management, allergy and infection. Elite operates a GMP and DEA registered facility for research, development, and manufacturing located in Northvale, NJ.
This news release contains forward-looking statements, including those related to the preliminary nature of the clinical program results and the potential for further product development, that involve known and unknown risks, delays, uncertainties and other factors not under the control of the Company, which may cause actual results, performance or achievements of the companies to be materially different from the results, performance or other expectations implied by these forward-looking statements. In particular, because substantial future testing will be required prior to approval, the results described above may not be supported by additional data or by the results of subsequent trials. These risks and other factors, including the timing or results of pending and future clinical trials, regulatory reviews and approvals by the Food and Drug Administration and other regulatory authorities, and intellectual property protections and defenses, are discussed in Elite's filings with the Securities and Exchange Commission such as the 10K, 10Q and 8K reports. The Company undertakes no obligation to update any forward-looking statements.