The multicenter, randomized, double-blind phase 3 study will evaluate the weight gain profile of ALKS
3831 compared to olanzapine, an established atypical antipsychotic agent with proven efficacy but also metabolic liabilities, in patients with stable schizophrenia over a six-month treatment period.
The US FDA's target action date for the NDA of ALKS
5461 for the adjunctive treatment of major depressive disorder (MDD) is 31 January 2019, added the company.
Subsequently, a drug-drug interaction study was performed to identify the ALKS
33 and buprenorphine ratio that would provide complete blockade.
The ENLIGHTEN clinical development programme for ALKS
3831 is comprised of two key studies: a study evaluating the antipsychotic efficacy of ALKS
3831 compared to placebo over four weeks, and a study assessing weight gain with ALKS
3831 compared to olanzapine in patients with schizophrenia over six months.
The company added that ALKS
5461 is a proprietary, investigational, once-daily oral medicine that acts as an opioid system modulator and represents a novel mechanism of action for the adjunctive treatment of major depressive disorder (MDD).
In an initial clinical trial, ALKS
33 at 10-mg and 20-mg oral doses completely blocked the effects of serial pulses of remifentanil in opioid-experienced volunteers.
3831 is an investigational, novel, oral atypical antipsychotic drug candidate composed of samidorphan, a novel, new molecular entity co-formulated with the antipsychotic agent, olanzapine, in a single bilayer tablet.
Biopharmaceutical company Alkermes (NasdaqGS:ALKS) reported on Monday the start of a phase 1 clinical study of ALKS
7106 for the treatment of pain.
Alkermes announced topline results from ENLIGHTEN-2, a pivotal phase 3 study of ALKS
3831, an investigational, novel, once-daily, oral atypical antipsychotic drug candidate for the treatment of schizophrenia.
- Cambridge, Massachusetts-based neurological and autoimmune disease therapies specialist Biogen (NASDAQ: BIIB) and Dublin, Ireland-based global biopharmaceutical company Alkermes plc (NASDAQ: ALKS
) have entered into a global license and collaboration agreement to develop and commercialize ALKS
8700, a novel, oral, monomethyl fumarate small drug molecule for the treatment of relapsing forms of multiple sclerosis (MS), the companies said.
M2 EQUITYBITES-July 31, 2014-Alkermes begins FORWARD-5 pivotal programme of ALKS
5461 for major depressive disorder
The "decidedly negative" FDA panel vote yesterday for ALKS
5461, while unsurprising following the briefing documents, put "significantly more pressure" on the pending ALKS
3831 Phase 3 readout in schizophrenia later this quarter, JPMorgan analyst Cory Kasimov tells investors in a research note titled "ALKS
Uphill Climb Fails to Reach the Summit." The analyst, however, believes yesterday's panel vote was broadly viewed as a "very high risk shot on goal" and notes he completely removed ALKS
5461 from his model last year.