HAL study compared subjective effects of drug liking, drug high and good drug effects between ELI-200 and the comparator formulation in non-dependent recreational drug users
Northvale, New Jersey, Tuesday, September 09, 2014: Elite Pharmaceuticals, Inc. ("Elite" or the “Company") (OTCBB: ELTP) today reported top line results from a Human Abuse Liability (HAL) study for the ELI-200 product. ELI-200 is an undisclosed abuse deterrent opioid product for pain.
The study results demonstrated statistically significant (p <.0001) lower measures of drug liking, drug high and good drug effects for Elite’s manipulated (crushed) ELI-200 when compared to the manipulated (crushed) drug listed comparator product and found 91.9% of the subjects experienced increased drug liking with the comparator product compared to ELI-200 in non-dependent recreational drug users when administered intranasally. The study also found 80.6% of the subjects experienced a decrease in drug liking with the intranasal crushed ELI-200 in comparison to the administration of oral intact ELI-200.
The data will be presented at the 16th Annual Rodman and Renshaw Global Investment Conference in New York City on September 9, 2014.
“We could not be more pleased with the top line result from the Human Abuse Liability Study for ELI-200 which confirms the effectiveness of our abuse deterrent technology,” said Nasrat Hakim, President and CEO of Elite Pharmaceuticals. “This successful technology will be the platform for an entire line of opioid products utilizing our proprietary technology. We remain on track to file our first new drug application for ELI-200 by December 2014.”
HAL Study Details
The HAL study was a single-center, randomized, double-blind, double-dummy, active- and placebo-controlled, single-dose, five-way crossover to evaluate the relative bioavailability, abuse potential and safety of crushed intranasal ELI-200 capsules compared to the crushed intranasal comparator product, oral intact ELI-200, and placebo in 37 healthy male and female non-dependent recreational opioid users with intranasal experience. The primary objective was to assess the abuse potential of ground ELI-200 relative to the crushed comparator product when administered intranasally to non-dependent, recreational opioid users with intranasal experience.
The secondary objectives were:
• To assess the abuse potential of crushed intranasal ELI-200 relative to placebo (intranasal and oral) in non-dependent, recreational opioid users with intranasal experience.
• To assess the abuse potential of oral intact ELI-200 relative to crushed intranasal ELI-200, crushed intranasal comparator, and placebo (oral and intranasal) in non-dependent, recreational opioid users with intranasal experience.
• To assess the relative bioavailability of the opioid in plasma from crushed intranasal and oral intact ELI 200 compared with one another and crushed comparator when administered intranasally in non-dependent, recreational opioid users with intranasal experience.
• To assess the safety of crushed intranasal and oral intact ELI-200 compared with crushed intranasal comparator and placebo (intranasal and oral) in non-dependent, recreational opioid users with intranasal experience.
The full report from the HAL studies is expected in October.
HAL studies are included in the FDA’s Guidance for Industry: Abuse-Deterrent Opioids - Evaluation and Labeling (January 2013). These studies are an important tool for the FDA to assess the relative abuse potential of a new drug. For drugs with abuse-deterrent properties, a HAL study assesses the impact of the potentially abuse-deterrent formulation on measures that predict how probable it is that the medication will be attractive to abusers. The industry guidance recommends that a Visual Analog Scale (VAS) be used to measure drug liking, drug high, good drug effects and other qualities.
Update on Other Development Programs
In addition, the Company also reports results from pivotal and pilot bioequivalence studies for ELI-202. The study results from the pivotal study for ELI-202 demonstrated Elite’s product, both the lowest strength and the highest strength, were bioequivalent for the opioid to the branded drug based on pharmacokinetic measures including peak concentration (Cmax) and area under the curve (AUC) for opioid blood plasma levels. ELI-202 is combination drug that contains a second drug and the study results for the second drug showed bioequivalence for AUC, but a lower Cmax. No food effect was seen with either drug. The study was a single dose, open label, partially randomized, three-way cross over study in healthy volunteers with 32 subjects under fasted conditions and under fed conditions.
Prior to receiving the complete and final report for this study, Elite initiated a pilot study to understand and address the lower Cmax for the combination drug. Two formulations were dosed in the pilot study and both formulations demonstrated that a repeat bioequivalence study with 32 subjects or more would be expected to be bioequivalent for the measured parameters. The pilot study was a single dose, open label, randomized, three period, crossover study in 8 healthy volunteers per arm under fasted conditions. A repeat bioequivalence study for ELI-202 is scheduled to begin in early October.
The formulations utilized Elite’s proprietary pharmacological abuse deterrent technology with the opioid antagonist naltrexone. Levels of sequestration of naltrexone were also evaluated and dosing of Elite’s intact formulation resulted in almost no exposure levels to naltrexone (LOQ of 4 pg/mL) and its metabolite 6--naltrexol (LOQ of 10 pg/mL) as intended.
“Our technology continues to perform as expected with positive outcomes,” continued Mr. Hakim. “There will be no impact on our target filing for ELI-202 in Q4 2015.”
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. 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. 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 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-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.