CONSHOHOCKEN, PA and VANCOUVER, BC, March 23 /CNW/ - Neuromed
Pharmaceuticals, Inc. today announced positive results of a pivotal phase 3
clinical trial of its lead investigational drug, Exalgo (hydromorphone HCl)
Extended-Release Tablets (CII) (previously NMED-1077 and OROS(R)
Hydromorphone). The trial met its primary efficacy endpoint, the mean change
from baseline to week 12 (or last visit) of average weekly pain intensity
scores, and the results were statistically significant (p(less than)0.0001).
The primary efficacy endpoint was agreed upon with the U.S. Food and Drug
Administration (FDA) during the Special Protocol Assessment (SPA) process(1).
Neuromed is seeking approval of Exalgo in the U.S. for the management of
moderate to severe pain in opioid tolerant patients requiring continuous,
around-the-clock opioid analgesia for an extended period of time. The FDA has
stated in an Approvable Letter that one successful adequate and
well-controlled clinical trial will be needed to support approval of Exalgo.
"The successful completion of our pivotal phase 3 clinical trial brings
us closer to reaching our goal of providing an effective once-daily pain
medication for opioid tolerant patients with moderate to severe pain requiring
around-the-clock opioid analgesia for an extended period of time," said Dr.
Christopher Gallen, President and Chief Executive Officer of Neuromed. "We
have now successfully completed a major milestone of our development plan and
are on schedule to submit our FDA application planned for the second quarter
Martin E. Hale, M.D., Principal Investigator of the pivotal phase 3
clinical trial stated, "Hydromorphone is a clinically proven analgesic that is
not currently available in a long acting oral formulation. Exalgo, if
approved, will provide an additional option in the treatment of chronic
moderate to severe pain in opioid tolerant patients."
Study Design and Results
The pivotal phase 3 clinical trial of Exalgo was a double-blind,
placebo-controlled study employing a randomized withdrawal design, conducted
at 65 centers in the U.S. The study randomized 268 opioid tolerant patients
with chronic moderate to severe low back pain for treatment of up to twelve
weeks. Patients were considered to be opioid tolerant if they were on chronic
opioid therapy at a dose equivalent to (greater than or equal to) 60 mg/day of
oral morphine for a period of time.
The primary efficacy endpoint was the mean change from baseline to week
12 (or last visit) of average weekly pain intensity scores compared to the
placebo group, measured using an 11-point Likert Numerical Rating Scale (NRS)
obtained from patient diaries. The study showed statistically significant
(p(less than)0.0001) results in the protocol specified primary efficacy
endpoint. In addition, results from statistical analyses of multiple secondary
efficacy endpoints were consistent with the primary efficacy endpoint.
The overall safety profile and reported adverse events in the study were
consistent with that of other strong opioids. The most commonly reported
adverse events in the study were nausea, constipation, vomiting, arthralgia,
insomnia and headache.(1) A SPA is a procedure by which sponsors and the FDA reach agreement on
the protocol design, primary efficacy endpoints, and the data
analysis of clinical trials needed to support approval of a New Drug
Application (NDA).About Exalgo
Neuromed acquired from ALZA Corporation the U.S. marketing rights to
Exalgo, an extended release formulation of hydromorphone. Hydromorphone is a
Schedule II opioid that has been used for many years. Oral hydromorphone
products currently available in the U.S. are immediate release formulations,
requiring dosing several times per day. Exalgo, if approved, will employ the
OROS(R) PUSH-PULL(TM) osmotic delivery system designed to release
hydromorphone at a controlled rate over an extended period of time. An
identical formulation, under the trade name JURNISTA(R), has been launched in
several countries by Janssen-Cilag. JURNISTA(R) was first launched in Germany
in August 2006.
Exalgo is an investigational drug and has not been approved by the FDA.
To date, Exalgo has been studied in more than 2,000 patients in clinical
trials. The most common adverse events seen in those clinical trials to date
are opioid-related events such as constipation, nausea, somnolence, headache,
vomiting and dizziness. Respiratory depression is the most important hazard of
opioid preparations including Exalgo.
Neuromed is a privately held biopharmaceutical company in business to
develop new and improved pain medicines. Neuromed has three programs aimed at
addressing this important unmet medical need. Its lead product, Exalgo is an
extended release formulation of hydromorphone in phase 3 clinical development.
In collaboration with Merck, Neuromed is also developing oral drug candidates
to block N-type calcium channels, a new and important target directly involved
in pain signaling. Its third program is focused on producing promising T-type
calcium channel blockers aimed at treating pain, epilepsy and hypertension.
For more information visit our website at www.neuromed.com.-------------------------------
OROS(R) and Push-Pull(TM) are trademarks of ALZA Corporation.Neuromed cautions you that statements included in this press release that
are not a description of historical facts may be forward-looking statements.
Forward-looking statements are only predictions based upon current
expectations and involve known and unknown risks and uncertainties. You are
cautioned not to place undue reliance on these forward-looking statements,
which speak only as of the date of release of the relevant information, unless
explicitly stated otherwise. Actual results, performance or achievement could
differ materially from those expressed in, or implied by, Neuromed's
forward-looking statements due to the risks and uncertainties inherent in
Neuromed's business including, without limitation, statements about: the
progress and timing of its clinical trials; difficulties or delays in
development, testing, obtaining regulatory approval, producing and marketing
its products; unexpected adverse side effects or inadequate therapeutic
efficacy of its products that could delay or prevent product development or
commercialization, or that could result in recalls or product liability
claims; the scope and validity of patent protection for its products;
competition from other pharmaceutical or biotechnology companies; and its
ability to obtain additional financing to support its operations. Neuromed
does not assume any obligation to update any forward-looking statements.
For further information: Karen Waller, Telephone: (202) 745-5056, Email: