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.
Teva Announces Recruitment Completion of Phase 3 Clinical Study of Olanzapine
Alkermes Announces Topline Results From Study of LYBALVI
Zydus Lifesciences has received final approval from the United States Food and Drug Administration (USFDA) to manufacture and market Olanzapine Orally Disintegrating Tablets USP, 5 mg, 10 mg, 15 mg, and 20 mg.
In situ amorphization is a promising approach, considered in the present work, to enhance the solubility and dissolution rate of olanzapine, while minimizing the exposure of the amorphous material to the stress conditions applied during conventional processing. The production of pellets by extrusion/spheronization and the coating of inert beads were investigated as novel methods to promote the co-amorphization of olanzapine, a poorly water-soluble drug, and saccharin. Samples were characterized using differential scanning calorimetry, X-ray powder diffraction, Fourier-transform infrared spectroscopy and scanning electron microscopy, and dissolution and stability testing. The co-amorphous produced were compared with crystalline olanzapine, or physical mixture of olanzapine and saccharin.
Awakn Life Sciences Signs Drug Development Agreement with Catalent for Zydis(R) Technology (An Orally Disintegrating Tablet) to Conduct Feasibility Studies to Improve Differentiation of Its MDMA Program
MONTPELLIER, France--(BUSINESS WIRE)--Teva Pharmaceuticals has notified MedinCell (Paris:MEDCL) that it made the decision to initiate the clinical Phase 3 trial for mdc?TJK.
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.