DUBLIN, April 8, 2024 /PRNewswire/ -- Alkermes plc (Nasdaq: ALKS) today announced the oral presentation of clinical data at the 2024 Congress of the Schizophrenia International Research Society (SIRS), which took place April 3-7, 2024 in Florence, Italy. Analyses were presented from a phase 3, open-label extension study assessing the long-term safety, tolerability and durability of treatment effect of LYBALVI® (olanzapine and samidorphan) in patients who received up to four years of treatment. LYBALVI is approved in the U.S. for the treatment of adults with schizophrenia, and for the treatment of adults with bipolar I disorder, as a maintenance monotherapy or for the acute treatment of manic or mixed episodes, as monotherapy or as adjunct to lithium or valproate.
Alkermes Announces Topline Results From Study of LYBALVI
Marketing drugs for mental illness is a unique challenge in pharma, and Alkermes is navigating COVID, stigma and a major generics market to get its new drug Lybalvi to patients.
DUBLIN, Feb. 8, 2022 /PRNewswire/ -- Alkermes plc (Nasdaq: ALKS) today announced positive topline results from ENLIGHTEN-Early, a phase 3b study that evaluated the effect of LYBALVI® (olanzapine and samidorphan) compared to olanzapine on body weight in young adult patients (ages 16 to 39; mean age: 26 years) with schizophrenia, schizophreniform disorder or bipolar I disorder who were early in their illness. The study met its pre-specified primary endpoint, as patients treated with LYBALVI experienced statistically significantly less weight gain than patients treated with olanzapine at Week 12 (mean percent change from baseline body weight: 6.77% for olanzapine vs. 4.91% for LYBALVI, p=0.012). Consistent with the ENLIGHTEN-2 pivotal study,1 a numerical difference in average weight gain between treatment arms was observed early in treatment and continued to separate through the study's prespecified primary endpoint.
Alkermes Plc (ALKS.O) said on Tuesday the U.S. Food and Drug Administration (FDA) had approved its treatment, Lybalvi, for schizophrenia and bipolar I disorder.
DUBLIN, Dec. 29, 2020 /PRNewswire/ -- Alkermes plc (Nasdaq: ALKS) today announced that the U.S. Food and Drug Administration (FDA) has acknowledged receipt of the company's New Drug Application (NDA) resubmission for ALKS 3831 (olanzapine/samidorphan) for the treatment of adults with schizophrenia and adults with bipolar I disorder, and has assigned the application a new Prescription Drug User Fee Act (PDUFA) target action date of June 1, 2021.
Alkermes plc (Nasdaq: ALKS) today announced the publication of results from the phase 3 ENLIGHTEN-1 clinical trial of ALKS 3831 (olanzapine/samidorphan) in the peer-reviewed publication, Journal of Clinical Psychiatry. ENLIGHTEN-1 was a four-week study evaluating the efficacy, safety and tolerability of ALKS 3831 compared to placebo in 403 patients experiencing an acute exacerbation of schizophrenia. Positive topline data from the ENLIGHTEN-1 study were first reported in June 2017. A New Drug Application (NDA) for ALKS 3831 is currently under U.S. Food and Drug Administration (FDA) review, with a Prescription Drug User Fee Act (PDUFA) target action date of Nov. 15, 2020.
Poking around proxy statements every year can deliver some interesting surprises. And this year has offered some doozies as companies hit with some of the biggest setbacks of recent times reported out some big hikes in compensation for their CEOs — as well as at least one Big Pharma-sized pay package for a team player at a biotech spinoff.
FDA advisors turn down Alkermes’ ALKS 5461
Alkermes plc (Nasdaq: ALKS) today announced that Molecular Psychiatry has published phase 3 clinical data for ALKS 5461 (buprenorphine/samidorphan), a once-daily, oral investigational 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 patients with an inadequate response to standard antidepressant therapies. The Molecular Psychiatry publication includes comprehensive efficacy and safety results from FORWARD-4 (Study 205) and FORWARD-5 (Study 207), and a review of a pooled analysis of the two datasets. Collectively, ALKS 5461 demonstrated a consistent profile of antidepressant activity, safety and tolerability in the adjunctive treatment of MDD.