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Lybrel set for UK launch in 2008

The first oral contraceptive pill to stop periods completely could be launched in the UK in 2008

The first oral contraceptive pill to stop periods completely could be launched in the UK in 2008, according to media reports.

Lybrel (levonorgestrel/ ethinyl estradiol), which is manufactured and marketed by US-headquartered pharma company Wyeth, is awaiting approval in the EU, but was approved in the US by the FDA in May 2007. It went on the US market in July 2007.

Although Lybrel is an oral contraceptive, and therefore prevents pregnancy, it looks likely that this will be marketed as more of a ìlifestyle drugî, with a focus more on the lack of a period and prevention of PMT than as a way to prevent pregnancy.

Despite the higher level of hormones in Lybrel, compared with other oral contraceptives, the FDA said: "The risks of using Lybrel are similar to the risks of other conventional oral contraceptives and include an increased risk of blood clots, heart attacks, and stroke."

When it was approved by the FDA in May 2007, the safety of Lybrel was supported by two one-year clinical studies, enrolling more than 2,457 women, aged between 18 and 49 years.

Health care professionals and patients are advised by the FDA that when considering the use of Lybrel, the convenience of having no scheduled menstruation should be weighed against the inconvenience of unscheduled bleeding, or 'spotting'.

The occurrence of unscheduled bleeding decreases over time in most women who continue to take Lybrel for a full year. In the primary clinical study, 59 per cent of the women who took Lybrel for one year had no bleeding or spotting during the last month of the study.

Wyeth's studies show that Lybrel completely stops bleeding in more than 70 per cent of women who take it for seven months or more, while PMT symptoms were eased.

The FDA has warned that the drug is not suitable for everyone; about half the women who tested it in trials dropped out before the end, citing irregular and unscheduled bleeding.

Despite Wyeth and the FDA's reassurances, many experts still warn against the risks of stopping periods completely, as it could mask infertility or unexpected pregnancies. The long term effects of suppressing menstruation are still unknown and could be unsafe, say some doctors. 

Lybrel comes in a 28 day-pill pack with low-dose combination tablets that contain 90 micrograms of the progestin, levonorgestrel, and 20 micrograms of the estrogen, ethinyl estradiol, which are active ingredients available in other approved oral contraceptives already on the market.

Continuous contraception works the same way as the 21 days on-seven days off cycle. It stops the body's monthly preparation for pregnancy by lowering the production of hormones that make pregnancy possible.

UK market
According to a 2007 Custom Research report, the UK market for contraceptives was worth GBP 164.5m (USD 332.8m) in 2007. Hormone-based products continue to perform well, particularly with oral contraceptives, while the latter is currently experiencing difficulties in terms of deflationary pressure on prices, which is affecting value levels.

Newer products, such as Schering Health's combined pill, Yasmin, and the progestogen-only pill Cerazette from Organon, have tended to take market share from other products, rather than to stimulate the sector as a whole.

In the UK, there has been a move toward long-acting reversible contraceptives (LARCs), which the National Institute for Health and Clinical Excellence (NICE) believes will be more effective methods, both in terms of contraception and cost, over the longer term. Schering Health and Berlex's Mirena intra-uterine system (IUS), which can last up to five years, has seen significant growth in the number of prescriptions issued in the UK. Organon's contraceptive implant Implanon is also seeing an increase in uptake.

27th September 2007

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