DUBLIN, May 20, 2020 /PRNewswire/ -- Alkermes plc (Nasdaq: ALKS) today announced that data from its phase 3b ALPINE (Aripiprazole Lauroxil and Paliperidone palmitate: INitiation Effectiveness) study were published in the Journal of Clinical Psychiatry. ALPINE was a six-month study evaluating the efficacy and safety of the ARISTADA INITIO® (aripiprazole lauroxil) one-day initiation regimen, consisting of ARISTADA INITIO and one single dose of 30 mg of oral aripiprazole, together with the ARISTADA® (aripiprazole lauroxil) two-month dose in patients experiencing an acute exacerbation of schizophrenia. Positive topline data were first reported in April 2019. Results from the study provide evidence to support the use of the ARISTADA INITIO one-day regimen together with ARISTADA for treatment of an acute exacerbation of schizophrenia, started in the hospital setting and continued through the critical transition to outpatient care.
DUBLIN, May 11, 2020 /PRNewswire/ -- Alkermes plc (Nasdaq: ALKS) today announced the expansion of several programs and services in support of patient access to its proprietary medicines during the COVID-19 crisis. During this unprecedented and rapidly evolving situation, the company remains focused on helping to assure that patients have uninterrupted access to ARISTADA® (aripiprazole lauroxil), an injectable atypical antipsychotic for the treatment of schizophrenia in adults, and VIVITROL® (naltrexone for extended-release injectable suspension), indicated for the treatment of alcohol dependence and the prevention of relapse to opioid dependence following opioid detoxification.
(Reuters) - Alkermes Plc said on Tuesday its long-acting injectable therapy for schizophrenia has helped reduce symptoms and can become an effective option for ensuring patients stay on medication even after being discharged from hospital.
Elliot Ehrich, M.D., who capped an 18-year career at Alkermes in January, has joined Expansion Therapeutics as its chief medical officer. The company closed a $55.3 million series A round in January to advance a pipeline targeting disease-driving RNAs.
Alkermes plc announced that the US Food and Drug Administration (FDA) has approved Aristada Initio (aripiprazole lauroxil) for the initiation of Aristada (aripiprazole lauroxil), a long-acting injectable atypical antipsychotic for the treatment of schizophrenia in adults.
Alkermes plc today announced that the U.S. Food and Drug Administration (FDA) has approved ARISTADA INITIO™ (aripiprazole lauroxil) for the initiation of ARISTADA® (aripiprazole lauroxil), a long-acting injectable atypical antipsychotic for the treatment of schizophrenia in adults.
Alkermes plc (Nasdaq: ALKS) today announced that new clinical data will be presented at the American Society of Clinical Psychopharmacology (ASCP) Annual Meeting in Miami, May 29 – June 1, 2018. The poster presentations will highlight data from the company's depression and schizophrenia portfolios, including ALKS 5461, ARISTADA® (aripiprazole lauroxil extended-release injectable suspension) and ALKS 3831.
DUBLIN--(BUSINESS WIRE)--Alkermes plc (NASDAQ: ALKS) today announced that the New Drug Application (NDA) for Aripiprazole Lauroxil NanoCrystal® Dispersion (ALNCD), a novel, investigational product designed for initiation onto ARISTADA® (aripiprazole lauroxil) extended-release injectable suspension for the treatment of schizophrenia, has been accepted for filing by the U.S. Food and Drug Administration (FDA). The FDA has issued a target action date for the ALNCD NDA of June 30, 2018 under the Prescription Drug User Fee Act (PDUFA).
DUBLIN--(BUSINESS WIRE)--Alkermes plc (NASDAQ: ALKS) today announced plans to initiate a phase 3b clinical study to evaluate the efficacy and safety of ARISTADA® (aripiprazole lauroxil) extended-release injectable suspension and INVEGA SUSTENNA® (paliperidone palmitate) in patients experiencing an acute exacerbation of schizophrenia. Subjects in the ARISTADA treatment arm will receive Aripiprazole Lauroxil NanoCrystal® Dispersion (ALNCD), a novel, investigational product designed for initiation onto ARISTADA, followed by the two-month dose of ARISTADA for a total of six treatment months. Alkermes recently submitted a New Drug Application (NDA) for ALNCD to the U.S. Food and Drug Administration (FDA).
Alkermes PLC’s stock soared in after-market trading Thursday after the biotech company released positive clinical data from its trial of an experimental depression drug.