Elite Pharmaceuticals Initiates Pivotal Bioequivalence Study for Third Opioid Abuse Deterrent Product
May 19 2014 - 8:15AM
Elite Pharmaceuticals, Inc. ("Elite" or the "Company") ("Elite")
(OTCBB:ELTP) announced today the first dosing of a pivotal
bioequivalence study in healthy volunteers for ELI-202, an
undisclosed opioid abuse deterrent product, utilizing Elite's
proprietary pharmacological abuse deterrent technology.
Two bioequivalence studies will be run together for ELI-202. The
first study is a single-dose, open-label, three treatment,
three-way crossover study in which 32 healthy adult subjects will
receive treatment in a partially randomized sequence. The primary
objective of this first study is to compare the bioavailability of
the Company's abuse deterrent product to that from the reference
listed drug under fasted conditions. The secondary objectives are
to compare the bioavailability of the Company's abuse deterrent
product under fasted and fed conditions, and to evaluate the safety
and tolerability of the Company's product. The second study is a
single-dose, open-label, two treatment, two-way crossover study in
which 32 healthy adult subjects will receive randomized
treatment. The primary objective of this second study is to
compare the bioavailability of the Company's abuse deterrent
product to that of the reference listed drug under fasted
conditions and the secondary objective is to evaluate the safety
and tolerability of the Company's product.
"Abuse of prescription narcotics is a serious problem in our
society and we are pleased to be working with new approaches to
help address this problem," said Nasrat Hakim, President and CEO of
Elite. "I have described my vision for a range of abuse
deterrent products that use Elite's proprietary pharmacological
abuse deterrent technology and I am pleased to announce initiation
of this pivotal study for ELI-202, one of several abuse deterrent
products currently under development by Elite. Our plans
include completing bioequivalency studies for a third abuse
deterrent product and doing In Vitro Lab Abuse Studies and human
abuse studies for the first product in 2014. I expect Elite to
file an NDA for its first abuse deterrent product with the FDA by
year's end."
Elite's development pipeline includes a range of opioid products
utilizing Elite's proprietary abuse deterrent
technology. Elite is currently working on five such abuse
deterrent products. Elite completed a successful pilot study
in December for a twice daily oxycodone product in which Elite's
formulation demonstrated bioequivalence to a brand comparator
product. A second abuse deterrent product, ELI-200,
successfully was demonstrated to be bioequivalent to the brand
comparator in a pivotal biostudy in January and now, a third abuse
deterrent product, ELI-202, has entered a pivotal bioequivalence
trials. A fourth product is expected to enter pivotal
bioequivalence studies later this year. Additional human and
laboratory abuse liability studies are also planned for these
products, and Elite expects to file it first abuse deterrent
product NDA by year's end.
The bioequivalence 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 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 has seven commercial products
currently being sold, eleven 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 include 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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