Contraceptive pills to help combat PMS move closer to winning UK regulatory approval
15 Oct 2007
Readers will be extremely interested to learn that YAZ, a 24-day oral contraceptive pill from Bayer HealthCare designed to be taken to combat PMS symptoms, has been granted approval for this use in the Netherlands.
YAZ is now registered in the Netherlands to be used as an oral contraceptive and for the treatment of moderate acne in women seeking contraception. The Netherlands will act as the Reference Member State for a Mutual Recognition Procedure hopefully to gain European-wide approval for the product as a PMDD treatment. YAZ has been available in the US since April 2006 and has become the fastest growing oral contraceptive brand there. Bayer claim it is the only oral contraception with clinically proven efficacy for treatment of PMS symptoms including the emotional and physical symptoms linked with Premenstrual Dysphoric Disorder (severe PMS) such as mood swings, irritability, anxiety, changes in appetite and eating habits, breast tenderness, bloating and headaches. For this reason many women will be keen to have access to this treatment option and we will keep readers informed about the progress made towards UK approval.
Astrid Kranz, Head of Global Product Communication at Bayer, told NAPS: “Regarding YAZ approval in Europe we are at the moment in the phase of the mutual recognition process and would like to launch it in 2008 in Europe. But no further details are available at the moment.”
Meanwhile the UK press has again been widely reporting on the imminent availability of a new contraceptive pill developed by Wyeth, which also aims to help combat symptoms associated with PMS. It is a sign of the changing priority given to PMS that this story was the front page lead in the Daily Mail on September 27.
Currently called Lybrel here, it has been approved by the Food and Drug Administration (FDA) as the first continuous contraceptive pill for prevention of pregnancy. It comes in a 28-day pill pack with low dose combination tablets allowing it to be taken without the pill-free time interval. Lybrel is already on sale in the US under the name of Anya, and according to the New Scientist it is hoped that it will be available in the UK next year.
Nick Panay, consultant gynaecologist at the Queen Charlotte and Westminster Hospitals, and Chairman of NAPS says: “We are in favour of this new regulated treatment option for women with cycle related symptoms, especially PMS."
