DUBLIN, Oct. 18, 2021 /PRNewswire/ -- Alkermes plc (Nasdaq: ALKS) today announced that LYBALVI® (olanzapine and samidorphan) is now available by prescription in the United States (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 an adjunct to lithium or valproate. LYBALVI is a once-daily, oral atypical antipsychotic composed of olanzapine, an established antipsychotic agent, and samidorphan, a new chemical entity.
Experience the interactive Multichannel News Release here: https://www.multivu.com/players/English/8657451-alkermes-fda-approval-availability-of-lybalvi-for-schizophrenia-and-bipolar-disorder-treatment/
"Alkermes has long been focused on the research, development and manufacture of new medicines that seek to address real-world patient needs and is committed to being a leader in the treatment of serious mental illness. Today, we're pleased to announce the commercial availability of LYBALVI, our first oral antipsychotic medicine, for adults living with schizophrenia or bipolar I disorder," said Todd Nichols, Chief Commercial Officer at Alkermes. "We have been building our commercial capabilities and presence in the antipsychotic market over the last five years and plan to leverage this experience as we expand our psychiatry franchise and bring LYBALVI to market. We look forward to engaging with healthcare providers and supporting patient access to LYBALVI as we drive awareness of this important new treatment option."
"Patients living with bipolar I disorder or schizophrenia commonly cycle through multiple therapeutic options in the course of their treatment journey. The availability of a new, efficacious and differentiated treatment option is a significant development for patients as they make treatment decisions with their healthcare provider," said Michael Pollock, CEO of the Depression and Bipolar Support Alliance (DBSA). "We appreciate Alkermes' long-standing dedication to the challenges faced by people living with serious and complex mental health conditions and to the development of medicines that seek to address unmet patient needs."
In the ENLIGHTEN clinical development program, LYBALVI demonstrated antipsychotic efficacy, safety and tolerability. Results from the ENLIGHTEN program's pivotal ENLIGHTEN-1 study in schizophrenia, which demonstrated antipsychotic efficacy compared to placebo, and ENLIGHTEN-2 study in schizophrenia, which demonstrated LYBALVI's effect on weight gain compared to olanzapine, as well as their respective 52-week extension studies, have been published in peer-reviewed journals.1,2,3,4 The U.S. Food and Drug Administration (FDA) approved LYBALVI under the 505(b)(2) regulatory pathway based on data from 27 clinical studies, including 18 studies evaluating LYBALVI and nine studies evaluating samidorphan alone, and the FDA's findings of safety and effectiveness of olanzapine in the treatment of bipolar I disorder and schizophrenia.5
Resources for Patients and Healthcare ProvidersThrough the company's LYBALVI Co-pay Savings Program, commercially insured eligible patients may qualify for a co-pay savings card that reduces patient out-of-pocket costs. In addition, Alkermes' Patient Assistance Program provides qualifying uninsured patients who meet eligibility requirements access to LYBALVI treatment at no charge for up to 12 months. Certain restrictions apply.
For U.S. healthcare providers, Alkermes' field sales force is available to conduct remote or in-person appointments and educational sessions. In addition, Alkermes has created the LYBALVI Care Support program, which provides resources and support to help appropriate patients access treatment prescribed by their healthcare providers. LYBALVI Care Support representatives can provide general coverage information, conduct a full benefit investigation, including a written summary of benefits (usually within 24 hours for patients enrolled in the program), and provide information about the Patient Assistance Program and LYBALVI Co-pay Savings Program.
To learn more, visit www.lybalvi.com or call 1-844-LYBALVI, Monday through Friday between 9 a.m. and 8 p.m. ET.
In addition, healthcare professionals, patients and caregivers with questions can reach Alkermes' Medical Information team by phone at 1-888-235-8008 (Direct: 1-571-599-2702) Monday through Friday between 9 a.m. and 7 p.m. ET or by sending an email to medinfo@alkermes.com. U.S. healthcare professionals are encouraged to visit the Alkermes Medical Information portal for assistance. Please note that this portal is for U.S. healthcare professionals only.
About Schizophrenia Schizophrenia is a serious brain disorder marked by positive symptoms (hallucinations and delusions, disorganized speech and thoughts, and agitated or repeated movements) and negative symptoms (depression, blunted emotions and social withdrawal).6 Schizophrenia affects approximately 1.1% of the U.S. population.7
About Bipolar I DisorderBipolar disorder is a brain disorder that is marked by extreme changes in a person's mood, energy and ability to function. Individuals with this brain disorder may experience debilitating changes in mood from extreme highs (mania) to extreme lows (depression). Bipolar I disorder is characterized by the occurrence of at least one manic episode, with or without the occurrence of a major depressive episode, and affects approximately one percent of the adult population in the United States in any given year.8
About the ENLIGHTEN Clinical Development ProgramThe ENLIGHTEN clinical development program for LYBALVI includes two key studies in patients with schizophrenia: ENLIGHTEN-1 and ENLIGHTEN-2.
ENLIGHTEN-1 evaluated the antipsychotic efficacy, safety and tolerability of LYBALVI compared to placebo over four weeks in 403 patients experiencing an acute exacerbation of schizophrenia. This study met its prespecified primary endpoint, with LYBALVI demonstrating statistically significant reductions from baseline in Positive and Negative Syndrome Scale (PANSS) scores compared to placebo (p