— Novel Oral Molecule Has Potential Benefits in Addiction and Other Central Nervous System Disorders —
“The data for ALKS 33 demonstrate our ability to develop new chemical
entities based on our unique understanding of biological pathways and
opioid pharmacology and sets the stage for the next phase of growth for
our pipeline,” said
Trial Designs and Results
ALK33-003 was a phase 1 randomized, double-blind, placebo-controlled, multi-dose study designed to assess the steady-state pharmacokinetics, safety and tolerability of ALKS 33. Thirty healthy subjects were randomized to receive seven consecutive, daily oral doses of one of two dose levels of ALKS 33 or placebo. In the study, ALKS 33 demonstrated rapid oral absorption and sustained pharmacologically active plasma levels that support once daily dosing.
ALK33-004 was a phase 1, randomized, single-blind, placebo-controlled, single-dose study designed to test the ability of ALKS 33 to block the subjective and objective effects of a potent opioid agonist, remifentanil, a commercially available analgesic. Twenty-four healthy, non-dependent, opioid-experienced subjects were randomized to receive a placebo dose as well as one of two dose levels of ALKS 33, the same doses investigated in ALK33-003. Data showed that the onset of action of ALKS 33 was rapid and observed as early as 15 minutes following oral administration. A full blockade of the opioid agonist was observed and sustained for more than 24 hours following a single administration of ALKS 33. ALKS 33 was generally well tolerated in both studies.
About Opioid Receptor Pathways
Opioid receptor pathways have biological activity throughout the body including the brain, gastrointestinal system, immune system and cardiovascular system. Consequently, opioid receptor pathways play a key role in a broad range of nervous system disorders such as pain, addiction, psychiatric disorders, gastrointestinal disorders and immune disorders. Opioid modulators can act as agonists, antagonists or partial agonists at opioid receptors throughout the body. Emerging biological research and new medicinal chemistry insights now allow for the development of novel opioid modulators with the potential to show enhanced activity at opioid receptor sites and could ultimately lead to improved therapeutic options.
About
Certain statements set forth above may constitute forward-looking
statements within the meaning of the Private Securities Litigation
Reform Act of 1995, including, but not limited to the potential
therapeutic value of Alkermes’ proprietary molecules targeting opioid
receptors, including ALKS 33, and Alkermes’ plans to continue
development of such proprietary molecules. 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 the
company’s business is subject to significant risk and uncertainties and
there can be no assurance that its actual results will not differ
materially from its expectations. These risks and uncertainties include,
among others: whether ALKS 33 will demonstrate sufficient efficacy and
safety in subsequent trials; potential changes in cost, scope and
duration of the clinical trials; and whether ALKS 33 will be approved by
regulatory authorities and subsequently commercialized. For further
information with respect to factors that could cause the company’s
actual results to differ materially from expectations, reference is made
to the reports the company filed with the
VIVITROL® is a registered trademark of
Source:
Alkermes, Inc.
For Investors:
Rebecca Peterson, 617-583-6378
or
For
Media:
Jennifer Snyder, 617-583-6166