Elite Pharmaceuticals Reports Successful Pivotal Bioequivalence Study for Abuse Deterrent Product ELI-200
March 05 2014 - 7:30AM
Elite Pharmaceuticals, Inc. ("Elite" or the "Company") (OTCBB:ELTP)
announced today successful results from a pivotal bioequivalence
study initiated in January 2014 for Elite's undisclosed abuse
deterrent opioid product, ELI-200. The study results demonstrated
Elite's product is bioequivalent to the branded drug based on
pharmacokinetic measures including peak concentration (Cmax) and
area under the curve (AUC) for opioid blood plasma levels. The
study was a single dose, open label, partially randomized,
three-way cross over study in healthy volunteers with 42 subjects
under fasted conditions and 38 subjects under fed conditions.
The formulation 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-β-naltrexol (LOQ of 10 pg/mL) as intended. Elite will proceed
with the development program for this product including completion
of a human abuse liability study. Elite expects to file an NDA for
this product by year end.
"As I have stated before, we have set in motion several
initiatives that will have significant impact on Elite's future,"
commented Nasrat Hakim, Elite's President and CEO. "Following
the success of the pilot bioequivalence study in December for
ELI-201, we are delighted with the results of this pivotal
bioequivalence clinical study for ELI-200, our second opioid abuse
deterrent product. ELI-200 is expected to be filed this year
and will be the first NDA product filed by Elite with the U.S. Food
and Drug Administration."
The bioequivalence studies for these opioid abuse deterrent
products are being conducted under the direction of Camargo
Pharmaceutical Services.
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 Section 505(b)(2)
The Company plans to file an NDA for this product based on the
provisions of section 505(b)(2) of the U.S. Food, Drug &
Cosmetic Act. Section 505(b)(2) allows the FDA to
approve a drug on the basis of data in the scientific
literature or data previously cited by the FDA as the basis
for the approval of related drugs. This procedure makes it
easier and potentially faster for drug developers to obtain
approval of new formulations of drugs based, in part, on
proprietary data of the developer of the original drug.
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 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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