Shire receives FDA approval of Equetro

The FDA has approved Shire Pharmaceuticals' Equetro (extended-release carbamazepine capsules), previously known as SPD417, for the treatment of patients with Bipolar Disorder.

Bipolar Disorder is one of the six leading mental disorders worldwide, according to the World Health Organisation¹. Each year, it is estimated that more than 2 million American adults^2,3, about 1% of the population age 18 and older⁴ are afflicted with Bipolar Disorder, also known as manic depression. Of the 750,000 currently diagnosed, about 650,000 are treated. The bipolar market in the United States is currently valued at about $1.9bn and is expected to grow to $2.4bn by 2007.

Bipolar Disorder is characterised by episodes of mania and depression, with periods of normal mood in between. The disorder can have devastating effects on an individual's life, although proper diagnosis and earlier treatment can usually alter the course of the illness.

Equetro significantly reduces the manic symptoms in Bipolar patients. Additionally, in clinical trials, patients treated with the product demonstrated no clinically significant weight gain or increase in blood glucose levels, thereby creating an effective tolerability profile. The unique three-bead extended release delivery system of Equetro provides for convenient administration as well. Available in 100, 200 and 300mg dosage strengths, it is the only carbamazepine formulation proven effective for patients with Bipolar Disorder.

Equetro has a formulation patent that runs until 2011 and will have three years market exclusivity under the US Hatch-Waxman Act. It will be available for prescribing in the US in the first quarter of 2005.

Matthew Emmens, Chief Executive of Shire commented: 'Bipolar Disorder is a debilitating condition that affects the patient and their family members. Equetro brings a new choice of treatment that can make a real difference to the lives of those who suffer from this distressing and serious illness.'