Elite Pharmaceuticals Begins Human Abuse Liability Studies for ELI-200
June 09 2014 - 8:00AM
Elite Pharmaceuticals, Inc. ("Elite" or the "Company") (OTCBB:ELTP)
today announced dosing of the first subject in the treatment phase
for a human abuse liability clinical study for ELI-200. ELI-200 is
an abuse deterrent product for an undisclosed opioid. The study is
a randomized, double-blind, double-dummy, active and
placebo-controlled five-way crossover study comparing crushed
ELI-200 capsules to a comparator product. The primary objective of
the study is to assess the abuse potential when administered
intranasally of ground ELI-200 relative to a crushed comparator
product and the secondary objectives include determining relative
bioavailability and safety of the product. Completion of the dosing
is expected in approximately 2 months. Final study results are
expected later this year.
"We are pleased to have this key study underway for ELI-200. The
study is a key part of the development program for ELI-200 and we
expect to file this product by year-end," 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. Elite has completed
a successful bioequivalence trial for ELI-200 earlier this year and
initiated in May a bioequivalence study for a second abuse
deterrent product. Our plans in 2014 include completing In Vitro
Lab Abuse Studies for ELI-200 and bioequivalence studies for a
third abuse deterrent product. Elite is excited to be developing
these new approaches to help address the prevalent issue of
prescription drug abuse."
The clinical studies for these opioid abuse deterrent products
are being conducted under the direction of Camargo Pharmaceutical
Services.
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'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, 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
Elite Pharmaceuticals (QB) (USOTC:ELTP)
Historical Stock Chart
From Mar 2024 to Apr 2024
Elite Pharmaceuticals (QB) (USOTC:ELTP)
Historical Stock Chart
From Apr 2023 to Apr 2024