Elite Pharmaceuticals Reports Results of Pilot Bioequivalence Study for ELI-201
February 18 2014 - 7:00AM
Elite Pharmaceuticals, Inc. ("Elite" or the "Company") ("Elite")
(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.
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.
CONTACT: Elite Pharmaceuticals, Inc.
Dianne Will, Investor Relations, 518-398-6222
Dianne@elitepharma.com
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