Elite Pharmaceuticals Initiates Pilot Bioequivalence Study for ELI-201
December 05 2013 - 12:49PM
Elite Pharmaceuticals, Inc. ("Elite" or the "Company") ("Elite")
(OTCBB:ELTP) announced today the first dosing of a pilot
bioequivalence study in healthy volunteers for ELI-201, the
Company's twice daily abuse deterrent oxycodone/naltrexone product.
Elite has met the goal of starting the bio study for ELI-201 in
December. A pivotal bioequivalence study for a second abuse
deterrent product is scheduled to begin dosing in January 2014, and
the pivotal bioequivalence study for ELI-201 is scheduled to begin
dosing in March 2014. The bioequivalence studies for these opioid
abuse deterrent products are being conducted under the direction of
Camargo Pharmaceutical Services.
"The start of the ELI-201 pilot study marks a major milestone
for the development of products utilizing our proprietary abuse
deterrent technology," said Nasrat Hakim, Elite's President and
CEO. "I am extremely pleased with the progress Elite has made with
the development of this technology. We have set several initiatives
in motion and all of our research and development projects are on
or ahead of schedule. We appreciate the guidance and expertise that
has been provided by Camargo and look forward to this next phase
for the Company."
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 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 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 six commercial products currently being sold, an additional
product approved and soon to be launched, eleven 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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