FDA expands indication of the only sublingual second-gen antipsychotic

The FDA has expanded the indication of the only sublingual atypical, or second-generation, antipsychotic to include pediatric patients aged 10 to 17 with bipolar I disorder.

Actavis' ($ACT) Saphris tablet, which is delivered via placement under the tongue, was approved in 2009 to treat bipolar I disorder and schizophrenia in adults. The new development adds 1.2 million U.S. children and teens to the potential market for the medication, Actavis says.

"We were pleased to see that Saphris was effective across a range of doses, in the largest registrational pediatric trial for an atypical antipsychotic in bipolar I disorder," said the company's executive vice president of global R&D, David Nicholson, in a statement. "Saphris is the first atypical antipsychotic to be approved for pediatric patients with bipolar I disorder in the last five years. As part of our commitment to mental health, we look forward to making this treatment option available to patients as soon as possible."

The company said the med resulted in improvement in scores on the Young Mania Rating Scale and Clinical Global Impression-Bipolar Severity of Illness assessments as compared with placebo in the pediatric clinical trial.

Saphris for pediatrics will be available as a 2.5-mg, 5-mg or 10-mg sublingual tablet in the black cherry flavor in Q2 2015.

Eleven atypical antipsychotic medications are available, according to the FDA. All are delivered orally, except sublingual Saphris. Pfizer's ($PFE) Geodon, Eli Lilly's ($LLY) Zyprexa and Otsuka's Abilify (co-marketed with Bristol-Myers Squibb) have injectable versions for intramuscular delivery as well.

Atypical antipsychotics are also known as second-generation antipsychotics. The National Institutes of Health says the second-generation meds are less likely to result in tardive dyskinesia, which results in uncontrollable muscle movements, than those of older, so-called typical antipsychotics. But the agency notes that people on the newer generation of meds should monitor their weight, glucose levels and lipid levels.

- read the release

Special Report: The FDA approvals of 2009

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