— Pharmacokinetic Data Support Aripiprazole Lauroxil’s Competitive
Features as Once-Monthly, Long-Acting Injectable Antipsychotic With
— Additional Efficacy Analyses of Phase 2 Study Results for ALKS 5461 Show Significant Responder and Remission Rates in Patients With Inadequate Response to Conventional Antidepressants —
Details for these presentations at the ACNP meeting include:
Poster M184: “ALKS 5461, a Novel Opioid Modulator, Produces Remission
and Decreases Core Depressive Symptoms and Anhedonia as an Adjunctive
Treatment: A Sequential Parallel Comparison Design Trial in Inadequate
Responders to Antidepressants” will be presented by
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Alkermes will present additional analyses that build on the previously reported phase 2 primary efficacy results for ALKS 5461 in patients with MDD, showing response rates and remission rates based on Montgomery-Åsberg Depression Rating Scale (MADRS) scores, as well as additional efficacy outcomes on two core depression symptom scales: the Anhedonia subscale of the MADRS and the Bech Melancholia Scale of the Hamilton Depression Rating Scale (HAM-D17). Since depression rating scales capture a range of symptoms, findings on the Anhedonia and Bech scales enable clinicians to evaluate a medication’s efficacy for the core features of depression, such as depressed mood and anhedonia, and not only secondary features like sleep problems.
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ALKS 5461 was evaluated in a phase 2, randomized, double-blind,
multicenter, placebo-controlled study, utilizing a sequential parallel
comparison design (SPCD) to assess the efficacy and safety of
once-daily ALKS 5461 as adjunctive treatment in patients with MDD. In
October 2013 , theU.S. Food and Drug Administration (FDA ) granted Fast Track status for ALKS 5461 for the adjunctive treatment of MDD in patients with an inadequate response to standard therapies, andAlkermes plans to begin the phase 3 program in early 2014.
Poster T137: “Aripiprazole Lauroxil (ALKS 9070), a Novel Once-Monthly
Prodrug of Aripiprazole, Achieves Therapeutically Relevant Levels and is
Well-Tolerated in Adult Patients With Schizophrenia Following Deltoid
Administration” will be presented by
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Alkermes will present pharmacokinetic data from a multicenter, randomized, open-label, single-dose study of aripiprazole lauroxil, assessing administration of aripiprazole lauroxil by either deltoid or gluteal injection. -
The clinical data from this pharmacokinetic study will be included in
a New Drug Application (NDA) to the
FDA for aripiprazole lauroxil for the treatment of schizophrenia. Aripiprazole lauroxil is designed to provide patients with once-monthly dosing of a medication that, once in the body, converts into aripiprazole, a molecule that is commercially available under the name ABILIFY®.Alkermes continues to expect topline results from the phase 3 study of aripiprazole lauroxil in the first half of 2014.
Further details on the ACNP Annual Meeting are available at: www.acnp.org.
About ALKS 5461
ALKS 5461 is a proprietary investigational medicine with a novel mechanism for the treatment of major depressive disorder (MDD). The mechanism of action for ALKS 5461 in the treatment of depressive symptoms is based on modulation of the opioid system in the brain, employing a balanced combination of agonism and antagonism of opioid receptors. ALKS 5461 consists of buprenorphine, a partial agonist, and ALKS 33, a potent mu-opioid antagonist, and is designed to be a once-daily, non-addictive medicine. Early clinical development of ALKS 5461 was funded through a grant from the National Institute on Drug Abuse (NIDA).
About Aripiprazole Lauroxil and LinkeRx®
LinkeRx is a novel, proprietary technology platform developed by
About
Note Regarding Forward-Looking Statements
Certain statements set forth in this press release constitute
“forward-looking statements” within the meaning of the Private
Securities Litigation Reform Act of 1995, including, but not limited to,
the clinical development and regulatory plans and timelines with respect
to aripiprazole lauroxil and ALKS 5461; and the timing of receipt and
disclosure of topline phase 3 study results for aripiprazole lauroxil.
The company cautions that forward-looking statements are inherently
uncertain. Although the company believes that such statements are based
on reasonable assumptions within the bounds of its knowledge of its
business and operations, the forward-looking statements are neither
promises nor guarantees and they are necessarily subject to a high
degree of uncertainty and risk. Actual performance and results may
differ materially from those projected or suggested in the
forward-looking statements due to various risks and uncertainties. These
risks and uncertainties include, among others: the phase 3 study of
aripiprazole lauroxil may not be successful and may not be completed in
a timely manner; aripiprazole lauroxil may not demonstrate sufficient
therapeutic effect or an acceptable safety profile; we plan to rely, to
a significant extent, on third-party clinical research organizations, or
CROs, to help us conduct clinical trials so the success and timing of
the trials is dependent on our ability to work with such CROs and their
performance; regulatory submissions may not occur or be submitted in a
timely manner; the company may be unable to manufacture successfully our
products; and those risks described in the
LinkeRx® is a registered trademark of
Source:
Alkermes:
For Investors:
Rebecca
Peterson, +1 781-609-6378
or
For Media:
Jennifer Snyder,
+1 781-609-6166