Asenapine to Offer a Generic Option for Patients with Schizophrenia and Bipolar Disorder

Asenapine to Offer a Generic Option for Patients with Schizophrenia and Bipolar Disorder

asenapineAsenapine, also known as Saphris, marketed by Merck, is an efficacious drug for patients suffering from schizophrenia and bipolar disorder. Classified as an antipsychotic medication, Asenapine, CAS# 65576-45-6 is available in sublingual tablets of 5 and 10 milligrams. With the patent of Saphris expiring on June 8, 2015, a generic form of this lifesaving drug will surely be a boon to patients in need of cost effective treatments for these devastating diseases.

Typically taken two times daily, at either a 5 or 10 milligram strength, it should be noted that asenapine is not for use in psychotic conditions related to dementia. Adverse effects may include hyperglycemia, a sensitivity to temperature extremes, dizziness, drowsiness, restlessness, constipation, dry mouth, insomnia, and weight gain. Asenapine can be used as monotherapy or as adjunctive therapy with lithium or valproate.

Dont Lie to Me - Lesley Grogan

Dont Lie to Me – Lesley Grogan

Patients with schizophrenia often have symptoms which include hearing voices, hallucinations and paranoia. Those people with bipolar I disorder experience alternating periods of depression and highs, as well as increased activity and restlessness and impulsive behavior. In clinical trials of Saphris the efficacy of treatment with this formidable drug was studied in three placebo and active-drug controlled clinical trials for patients diagnosed with schizophrenia. Of these trials two demonstrated a superior response rate when compared to the placebo patient group, for controlling symptoms of schizophrenia. There were studies conducted for patients with bipolar disorder as well, specifically two placebo and active-drug controlled trials of Saphris. Both of these studies, conducted by both the FDA and Merck, indicated complete success for both trials. When compared to the placebo group, Saphris, or asenapine, was extremely effectual in treating the active symptoms of bipolar disorder.

With a known 1.1 percent of the U.S. population suffering from schizophrenia, the documented number is undoubtedly higher, as many patients do not seek treatment due to debilitating manifestations of this disease. According to The National Institute of Mental Health, 2.6 percent of the population in the U.S. is diagnosed with clinical bipolar disorder. Of these patients, a staggering 82.9 percent of these patients are classified as having a severe form of bipolar disorder. These numbers clearly tell the medical and pharmaceutical community that affordable drug treatment is needed for so many Americans with this disease. Research and development is crucial for meeting the future needs of people enduring life with both schizophrenia and bipolar disorder. LGM Pharma is a provider of the API asenapine, and offers complete support to clients throughout the R&D process.


Products currently covered by valid US Patents are offered for R&D use in accordance with 35 USC 271(e)+A13(1). Any patent infringement and resulting liability is solely at buyer risk.

  • Share:

LGM Pharma Acquires CDMO

On July 27, 2020, LGM Pharma announced its acquisition of the formulation development and drug product contract manufacturing business of Nexgen Pharma, Inc. As a result, you will notice our new logo and visuals throughout the website. We’re working on updates to reflect the exciting, expanded CDMO capabilities and services we now can offer you.

This website uses cookies. By using our site, you agree to our terms of service