News Feature | January 28, 2014

Lundbeck Reports Positive Phase III Results Of Depression Treatment Brexpiprazole

Source: Clinical Leader

By Estel Grace Masangkay

H. Lundbeck and partner Otsuka have reported positive Phase III results for brexpiprazole serotonin-dopamine activity modulator (SDAM) as an adjunct to antidepressant therapy. Brexpiprazole was discovered by Otsuka under co-development with Lundbeck.

Brexpiprazole (OPC-34712) is an investigational psychotherapeutic compound intended as a novel treatment for major depressive disorder (MDD) and schizophrenia. The drug is a SDAM which acts as a partial agonist at 5-HT1A and dopamine D2 receptors at the same potency. It also acts as an antagonist at 5-HT2A and noradrenaline alpha1B receptors. Brexpiprazole is speculated to be more effective and tolerable than standard adjunctive MDD treatments.

Phase III results from the Pyxis trial demonstrated significant improvements in 18 to 65 year old patients with MDD with inadequate response to antidepressant monotherapies. Lundbeck stated the following results data on brexpiprazole as an adjunct to antidepressant therapy in MDD:

  • Statistically significant improvements in mean MADRS total score for patients receiving adjunctive brexpiprazole compared with placebo. MADRS (Montgomery—Åsberg Depression Rating Scale) is a commonly used scale to assess the range of symptoms in patients with major depression
  • A statistically significant advantage over placebo on all secondary endpoints.
  • Most common (>5% and more than twice placebo) adverse events reported in the patients receiving adjunctive brexpiprazole included weight gain and akathisia (inner restlessness)
  • Over 90% of patients completed the randomized phase of the trial

The drug also showed statistically significant superiority for all secondary outcome change measures based on the Sheehan Disability Scale to week 14 of patient treatment.

Aside from MDD, Lundbeck and Otsuka plan to evaluate Brexpiprazole in patients with agitation rooted in dementia of the Alzheimer’s type, as well as in adults with posttraumatic stress disorder (PSD).

Lundbeck and Otsuka expect to complete three more Brexpiprazole trials on MDD and schizophrenia in the first two quarters of 2014. Otsuka said study results will determine if brexpiprazole could be filed for regulatory approval in the US this year.

Source:

http://investor.lundbeck.com/releasedetail.cfm?ReleaseID=820980