US FDA clears new indications for B-MS/Otsuka's Abilify and Pfizer's Geodon

Ahead of the weekend, the US Food and Drug Administration cleared additional indications for currently-marketed drugs from US drug majors Bristol-Myers Squibb and Pfizer, as well as a new formulation for the latter

For B-MS and partner Japan's Otsuka Pharmaceutical, the FDA has approved the supplemental New Drug Application for Abilify (aripiprazole) for the treatment of irritability associated with autistic disorder in pediatric patients aged six to 17 years, including symptoms of aggression towards others, deliberate self-injuriousness, temper tantrums, and quickly changing moods.

Abilify is already B-MS's second-biggest drug, generating $2.2 billion in 2008 sales. Several other drug companies sell products that compete with Abilify. One is Schering-Plough's (now Merck & Co) Saphris (asenapine), used to treat schizophrenia and bipolar disorder. Others include Pfizer Geodon (ziprasidone), and older drugs from Johnson & Johnson, AstraZeneca and Eli Lilly, which have combined annual sales of over $15.billion.

While there is no approved treatment for the core symptoms of autistic disorder, irritability can be an associated behavior of autistic disorder and is manifested as aggression towards others, deliberate self-injurious behaviors, temper tantrums, aggression and quickly changing moods, noted B-MS in a statement. Behavioral problems such as irritability can be a source of impairment or distress to an individual with autistic disorder.

The approval of ABILIFY for this indication is based on data from two eight-week, randomized, double-blind, placebo-controlled, multi-center, Phase III studies in which ABILIFY, compared to placebo, significantly improved scores on the Irritability subscale of the caregiver-rated Aberrant Behavior Checklist (ABC-I).

Expanded approval for Pfizer's Geodon

The FDA also approved Pfizer's Geodon (ziprasidone HCI) capsules for maintenance treatment of bipolar I disorder as an adjunct to lithium or valproate in adults. The approval is based on clinical data demonstrating that Geodon is an effective and generally well-tolerated adjunctive treatment for long-term symptom control in patients with bipolar disorder.

'The FDA approval of Geodon provides an additional treatment option for patients with bipolar disorder, who require maintenance therapy to keep the symptoms of the disease under control," said Charles Bowden, clinical professor of psychiatry and pharmacology, University of Texas Health Science Center.

The efficacy and safety of Geodon for the adjunctive maintenance treatment of bipolar disorder were studied in a six-month, double-blind, randomized, placebo-controlled trial in adult patients with bipolar I disorder. After an open-label stabilization period of 10 to 16 weeks, 240 patients were randomized to continue on Geodon plus lithium or valproate, or to have Geodon replaced by placebo. The primary endpoint in this study was time to recurrence of a mood episode requiring intervention.

IV Revatio approved

Pfizer said that an intravenous version of its high blood pressure drug Revatio (sildenafil) Injection was also cleared by the agency, noting that this is the only FDA-approved phosphodiesterase-5 (PDE5) inhibitor available in both tablet and intravenous formulations. The drug was already sold as a tablet. It is used as a treatment for adults with pulmonary arterial hypertension, which affects about 100,000 people worldwide.