Elite Pharmaceuticals Reports Results of Pilot Bioequivalence Study for ELI-201
...Provides Update on Pivotal Study for Second Opioid Abuse Deterrent Product and Manufacturing Transfer of Generic Products
Northvale, New Jersey, Tuesday, February 18, 2014:
Elite Pharmaceuticals, Inc. ("Elite" or the "Company") (OTCBB: ELTP) announced today successful results from a pilot bioequivalence study initiated in December 2013 for ELI-201, a twice-daily opioid abuse deterrent oxycodone product with abuse deterrent technology. Three different twice daily formulations developed by Elite were tested in the study. The study results demonstrate that all formulations in the study were bioequivalent to the reference drug based on pharmacokinetic measures including peak plasma concentration (Cmax) and area under the curve (AUC) for oxycodone blood plasma levels. The study was a single dose, open label, randomized, four period, four treatment, cross over study in 16 healthy volunteers under fasted conditions.
The formulations tested utilize Elite's proprietary pharmacological abuse deterrent technology with the opioid antagonist naltrexone. Levels of sequestration of naltrexone were evaluated based upon a naltrexone assay with a level of detection (LOD) of 4 pc/mL. The study results demonstrated that Elite's formulations were superior to an approved and marketed comparator product using a similar pharmacological approach. The comparison was based upon publicly available data from a similar fasted study in healthy volunteers and using a similar naltrexone assay with an LOD of 4 pc/mL. The primary metabolite of naltrexone, 6-Beta-natrexol, was also analyzed in the Elite study although no data from the comparator product was available for direct comparison.
As previously announced, Elite initiated a pivotal bioequivalence study for an undisclosed opioid abuse deterrent product in January and dosing for this study has now been completed. Results from the study are expected in March.
In addition, supplements are being prepared to file with the FDA for manufacturing site transfers for the first four of twelve approved generic products. Elite expects to file a Changes Being Effected in 30 days (CBE-30) in March for Isradipine, 2.5 mg and 5.0 mg capsules for transfer of manufacturing of this product to Elite's facility. Elite also expects that its partner, Epic Pharma, will file with the FDA a CBE-30 for Dantrolene Sodium, 25 mg, 50 mg and 100 mg capsules, Loxapine 5mg, 10mg, 25 mg, 50 mg capsules and Hydroxyzine 10 mg, 25 mg, 50 mg tablets for transfer of manufacturing of this product to Epic's facility in June. Although we hope to launch the products 30 days after these filings, Elite cannot guarantee when these products will launch as it is dependent on FDA acceptance of the filing.
"We are delighted with the results from our clinical studies and pleased to have confirmation of the formulation for our extended release product, ELI-201, our twice-daily oxycodone product and the progress of the second opioid," stated Nasrat Hakim, President and CEO for Elite. "We are also on track with the manufacturing site transfer of the twelve generic products Elite is adding to the product line. The transfers of these products have been prioritized and we will have additional supplements to file following these first two products."
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's strategy includes assisting partner companies in the life cycle management of products to improve off-patent drug products and developing generic versions of controlled release drug products with high barriers to entry. Elite has seven commercial products currently being sold, twelve 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 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, 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.
Contact:
Elite Pharmaceuticals, Inc.
Dianne Will, Investor Relations
518-398-6222
Dianne@elitepharma.com
