When was saphris released

The FDA approved Saphris for the acute treatment of pediatric patients with bipolar I disorder, according to an Actavis press release. Saphris asenapine, Actavis is an atypical antipsychotic used for manic or mixed episodes associated with the disorder. It is available in sublingual tablet form. The approval is based widely on results from a 3-week monotherapy trial assessing the safety and efficacy of the drug in pediatric patients aged 10 to 17 years. Of those, patients were administered Saphris twice daily at dosage strengths of 2.

Common adverse events included sleepiness, dizziness, strange sense of taste, numbing of the mouth, nausea, increased appetite, feeling tired, and weight gain. Saphris is currently available in 5 mg and 10 mg sublingual tablets for adult patients. It will now also be available on the 2. Sign In or Create an Account.

User Tools. Sign In. Skip Nav Destination Article Navigation. Close mobile search navigation Article navigation. Volume 1, Issue 6. Previous Article Next Article. Article Navigation. Research Article December 01 Saphris: Does a unique delivery system equal a unique drug?

Gable, Pharm. This Site. Google Scholar. Mental Health Clinician 1 6 : — Get Permissions. Cite Icon Cite. Asenapine , Saphris , antipsychotic , schizophrenia , acute mania , bipolar disorder. Asenapine for schizophrenia and bipolar disorder: a review of the efficacy and safety profile for this newly approved sublingually absorbed second-generation antipsychotic. DOI: Search ADS. Efficacy and safety of asenapine in a placebo-and haloperidol-controlled trial in patients with acute exacerbation of schizophrenia.

A 3-week, randomized, placebo-controlled trial of asenapine in the treatment of acute mania in bipolar mania and mixed states. Asenapine in the treatment of acute mania in bipolar I disorder: a randomized, double-blind, placebo-controlled trial.

Accessed November, Efficacy and tolerability of asenapine in acute schizophrenia: a placebo-and risperidone-controlled trial. Send Email Recipient s will receive an email with a link to 'Saphris: Does a unique delivery system equal a unique drug? Recipient Often, younger patients with bipolar I disorder experience more frequent mood episodes than adults.

The FDA approval of SAPHRIS was based on the results of a 3-week monotherapy trial in pediatric patients ages 10 17 , the largest registrational pediatric bipolar I mania trial for an atypical antipsychotic to date. The most common side effects that occurred with SAPHRIS were sleepiness, dizziness, strange sense of taste, numbing of the mouth, nausea, increased appetite, feeling tired, and weight gain.

Allergan is committed to helping patients access our medicines. A co-pay card is available on www. SAPHRIS is indicated for the acute treatment of manic or mixed episodes associated with bipolar I disorder as monotherapy in adults and pediatric patients ages 10 17 , or as adjunctive therapy with either lithium or valproate in adults. Elderly people with dementia-related psychosis having lost touch with reality due to confusion and memory loss taking antipsychotic drugs are at an increased risk for death.

Get emergency medical help if you are having an allergic reaction eg, difficulty breathing; itching; swelling of the face, tongue, or throat; or light-headedness.