Elite Pharmaceuticals Initiates Pivotal Bioequivalence Study for ELI-201
July 15 2014 - 10:31AM
Elite Pharmaceuticals, Inc. ("Elite" or the "Company") (OTCBB:ELTP)
announced today the first dosing of a pivotal bioequivalence study
in healthy volunteers for ELI-201, the Company's twice daily abuse
deterrent oxycodone/naltrexone product, utilizing Elite's
proprietary pharmacological abuse deterrent technology.
The study is an open-label, single-dose, partially-randomized
crossover study in healthy adult subjects. The primary objective of
this study is to compare the bioavailability and establish
bioequivalence of ELI-201 controlled-release capsules, 40 mg to
OxyContin® controlled-release tablet, 40 mg. The secondary
objectives include determining the bioavailability of oxycodone
from ELI-201 under fasted and fed conditions and evaluating the
safety and tolerability of ELI-201.
"We are pleased to have initiated our third key bioequivalence
trial this year for Elite's abuse-deterrent opioid products," said
Nasrat Hakim, Elite's President and CEO. "Elite has a range of
abuse deterrent products that use Elite's proprietary
pharmacological abuse deterrent technology and this is one of
several abuse deterrent products currently under development by
Elite. Our plans for the second half of 2014 include completing In
Vitro Lab Abuse studies and In Vivo Human Abuse Liability studies
and filing an NDA for ELI-200. Elite is excited to be developing
these new approaches to help address the prevalent issue of
prescription drug abuse."
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 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 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.
CONTACT: Elite Pharmaceuticals, Inc.
Dianne Will, Investor Relations, 518-398-6222
Dianne@elitepharma.com
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