Once a day pill promises period-free contraception

pharmafile | October 20, 2005 | News story | Sales and Marketing |   

The world's first-ever contraceptive pill to offer women complete freedom from menstruation could be launched by next year.

Wyeth's Lybrel is a low-dose oral contraceptive combining two well-established drugs (levonorgestrel 0.09mg and ethinylestradiol 0.02mg) in a single tablet to be taken 365 days a year.

The drug has been developed for women who find the current need to stop taking the pill for one week every month inconvenient, and for those who suffer from the hormonal fluctuations to which this can contribute.

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Wyeth has presented the first data relating to the drug which showed the drug was 98% effective in preventing pregnancy (the same as existing treatments) and produced a complete elimination of periods, reversible when the medication is stopped.

The company says its studies also showed patients with a history of cycle-related symptoms or PMS reported a decrease in their symptoms with continued use of the product.

Some existing products are taken daily, but these include one week's worth of inactive pills to allow menstruation to take place.

Lybrel was filed with the FDA in July and could be launched in the US by the middle of 2006, with analysts Deutsche Bank forecasting peak global sales of $300 million.

Tanaproget is another contraceptive drug in Wyeth's late stage pipeline. The drug is a tissue-selective, non-steroidal contraceptive progesterone receptor agonist (ovulation inhibition). Wyeth says the drug has a better side-effect profile than existing steroid-based contraceptives.

The drug is due for filing in 2006 and could earn peak worldwide sales of $300 million.

 

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