Wyeth, along with Belgian partner Solvay and Lundbeck of Denmark has presented promising data from a late-stage trial of their new schizophrenia compound bifeprunox.
The companies, who were presenting at the American Psychiatric Association meeting in San Diego, said that new analyses of six-month data from a Phase III study in stabilised adult patients with schizophrenia demonstrated that bifeprunox, maintained stability and displayed a favourable weight and lipid profile when compared with placebo.
The analyses showed that bifeprunox significantly prolonged time to deterioration over six months, while patients taking the drug experienced decreases in body weight and body mass index versus placebo. Bifeprunox patients also showed favourable effects on total cholesterol, triglycerides, very low-density lipoprotein and low-densitylipoprotein, comparable with placebo over the six-month period. The most common side effects reported with the compound included nausea, vomiting, dizziness, anorexia, akathisia, dyskinesia and asthenia.
The firms are expecting to hear from the US Food and Drug Administration this summer to see whether bifeprunox is approvable and they hope to be in a position to launch in the USA in early 2008. However in November 2005, Lundbeck delayed filing for approval of the treatment in Europe until 2008 as it carries out additional Phase III testing.
Wyeth’s Lybrel contraceptive approved
Wyeth also noted that the FDA has approved Lybrel (ethinyl estradiol and levonorgestrel), which the firm said is intended for women who are seeking contraception “and who are interested in putting their menstrual cycle on hold”.
Lybrel works by providing a steady low dose of hormones so that over time women may become cycle-free. The agency noted that most subjects in the clinical studies experienced some breakthrough bleeding and spotting, especially during the first three to six months but said that Lybrel did not delay a return to fertility nor did it affect return to menses.
The product is expected to generate sales of around $250 million and will compete with Barr’s Seasonale (levonorgestrel and ethinyl estradiol), which reduce periods to four a year.