Alkermes Initiates Clinical Study Of ALKS 5461 For Treatment-Resistant Depression

Alkermes Initiates Clinical Study Of ALKS 5461 For Treatment-Resistant Depression

Alkermes, Inc. (NASDAQ: ALKS) today announced the commencement of a phase 1/2 study of ALKS 5461 in favor of treatment-resistant depression (TRD). ALKS 5461 is the combination of ALKS 33, a proprietary opioid modulator, and buprenorphine. TRD, that is also known as refractory low spirits, refers to depressive episodes that are not adequately controlled ~ dint of. standard antidepressant therapy. The multicenter, randomized, double-stratagem, placebo-controlled trial is designed to assess the close custody and potential efficacy of ALKS 5461 in subjects by TRD. Alkermes expects to provide topline results from this study in the support half of calendar 2011.

"Many patients by depression do not adequately respond to existing pharmacological therapies, underscoring the unmet poverty for this serious and chronic complaint," stated Elliot Ehrich, Chief Medical Officer of Alkermes. "The confederacy of ALKS 33 with buprenorphine to appoint ALKS 5461 leverages our expertise by opioid modulators and may create a non-addictive therapy since treatment-resistant depression."

The phase 1/2, multicenter, randomized, double-leading nowhere, placebo-controlled, parallel-group, multi-drench study is designed to evaluate the preservation and tolerability of ALKS 5461 in 32 patients with major depressive disorder who had shown each inadequate response to previous antidepressant therapy. Two many ratios of the components will have ~ing given in an escalating dose titration formerly daily for seven days via sublingual the ministry. The pharmacokinetics and efficacy of ALKS 5461 enjoin also be evaluated.

ALKS 5461 is designed to exist a non-addictive, kappa antagonist ~ the sake of the treatment of TRD. Preclinical research has demonstrated that kappa blockade has antidepressant furniture in behavioral models of depression. Both components of ALKS 5461 accept established activity at mu opioid receptors, by ALKS 33 functioning as an rival of the mu receptor and buprenorphine in the same proportion that a partial agonist. The net weight of this combination may attenuate buprenorphine's mu agonist furniture, therefore making it potentially non-addictive.

About ALKS 5461

ALKS 5461 is the conjunction of ALKS 33 and buprenorphine. ALKS 33 is some oral opioid modulator that builds attached Alkermes' scientific expertise in opioid biology and pharmacology, to the degree that well as the company's clinical and commercial knowledge in the field of addictedness and central nervous system disorders. Clinical studies of ALKS 33 in to boot 400 patients to date have shown that it is in general well tolerated with a duration of achievement consistent with once-daily dosing. ALKS 5461 is moreover in clinical development for the manipulation of cocaine addiction, which is root funded through a grant from the National Institute adhering Drug Abuse (NIDA).

About Depression and TRD

Depression is a in earnest and chronic disease that affects additional than 20 million American adults either year,1 and finding the lawful treatment can be difficult for crowd patients. Approximately half of depressed patients be obliged an inadequate response to monotherapy,2 and since many as 20% have chronic hollow despite multiple interventions.3 TRD is diagnosed which time a patient has an inadequate answer to trials of two or to a greater degree antidepressant therapies.

1 Kessler RC, Chiu WT, Demler O, Walters EE. Prevalence, gravity, and comorbidity of twelve-month DSM-IV disorders in the National Comorbidity Survey Replication (NCS-R). Archives of General Psychiatry, 2005 Jun; 62 (6): 617-27.

2 Bauer M, Whybrow PC, Angst J, et al. World Federation of Societies of Biological Psychiatry (WFSBP) Guidelines notwithstanding Biological Treatment of Unipolar Depressive Disorders, Part 1: Acute and protraction treatment of major depressive disorder. World J Biol Psychiatry, 2002; 3:5-43.

3 Paykel ES. Epidemiology of unmanageable depression. In: Nolen WA, Zohar J, Roose SP, et al, editors. Refractory dumps: current strategies and future directions. New York: Wiley; 1994:3-18.