Avenue Therapeutics Announces Agreement with the FDA on the Study Design and Analysis Approach of the Phase 3 Safety Study for IV Tramadol
25 Luglio 2023 - 2:30PM
Avenue Therapeutics, Inc. (Nasdaq: ATXI) (“Avenue” or the
“Company”), a specialty pharmaceutical company focused on the
development and commercialization of therapies for the treatment of
neurologic diseases, today announced that it has reached agreement
with the U.S. Food and Drug Administration (“FDA”) on key elements
of the Phase 3 safety study, including the primary endpoint and
statistical analysis approach, for intravenous (IV) tramadol, which
is in development for the treatment of acute post-operative pain in
a medically supervised setting. The agreed upon non-inferiority
study is designed to assess the theoretical risk of opioid-induced
respiratory depression related to opioid stacking on IV tramadol
compared to IV morphine.
The study will randomize post bunionectomy
patients to IV tramadol or IV morphine for pain relief administered
during a 48-hour post-operative period. Of note, IV tramadol
demonstrated safety and efficacy in this same surgical model in a
Phase 3 efficacy trial. Patients will have access to IV
hydromorphone, a Schedule II opioid, for rescue of breakthrough
pain. The primary endpoint is a composite of elements indicative of
respiratory depression.
"Based on IV tramadol's innovative mixed
modality mechanism of action (agonism at the opioid mu receptor and
reuptake inhibitor of serotonin and norepinephrine), decades of
clinical experience in Europe and around the world, as well as the
program’s positive data in two Phase 3 trials, we believe that IV
tramadol will prove to be safe and effective in this final study
and patient population," said Alexandra MacLean, M.D., Chief
Executive Officer of Avenue. “With over 100 million acute pain
cases in the U.S. reported annually, patients and physicians seek
an alternative pain management option with the potential to reduce
the use of conventional opioids and the associated abuse potential
in the post-operative setting, while effectively managing patient’s
pain. We are confident that IV tramadol has the potential to
overcome limitations of existing therapies and make a meaningful
difference in the U.S. pain treatment landscape.”
Avenue is submitting the revised protocol to the
FDA including the statistical plan, which reflects the now agreed
upon study design, for final review. "Our goal is to initiate the
Phase 3 safety study this year, subject to obtaining the necessary
financing which could be provided through a strategic partnership,
and we expect that a positive study outcome could result in the FDA
approval of IV tramadol. Additionally, we plan to provide updates
on Avenue’s two earlier-stage clinical programs in the coming
weeks, including our lead product candidate, AJ201 to treat spinal
and bulbar muscular atrophy, and BAER101 for epilepsy. We remain
committed to Avenue’s mission of delivering impactful therapies to
treat patients with neurologic diseases, while building shareholder
value,” said Dr. MacLean.
About Avenue TherapeuticsAvenue
Therapeutics, Inc. (Nasdaq: ATXI) is a specialty pharmaceutical
company focused on the development and commercialization of
therapies for the treatment of neurologic diseases. It is currently
developing three assets including AJ201, a first-in-class asset for
spinal and bulbar muscular atrophy, BAER101, an oral small molecule
selective GABA-A α2/3 receptor positive allosteric modulator for
CNS diseases, and IV tramadol, which is in Phase 3 clinical
development for the management of acute postoperative pain in
adults in a medically supervised healthcare setting. Avenue is
headquartered in Miami, FL and was founded by Fortress Biotech,
Inc. (Nasdaq: FBIO). For more information, visit
www.avenuetx.com.
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statements made by us in light of these important factors.
Contact: Jaclyn JaffeAvenue Therapeutics, Inc.
(781) 652-4500ir@avenuetx.com
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