Pfizer has launched a self-injectable contraceptive called Sayana Press (medroxyprogesterone acetate) for women in the UK.
Sayana Press is a combination of a long-acting, reversible contraceptive, and an all-in-one prefilled, single-use, non-reusable Uniject injection system, reducing the need to prepare a needle and syringe.
The company said that each subcutaneous injection prevents ovulation and provides contraception for around 13 weeks.
The launch of Sayana Press allows women in the UK to inject the contraceptive themselves at home rather than going to a clinic or GP surgery.
Recently, the UK Medicines and Healthcare Products Regulatory Agency (MHRA) has extended the label for Sayana Press, adding the option for self-injection by women when considered appropriate by a healthcare professional (HCP).
The company started development of the product after the MHRA extended the label.
Pfizer Global Established Pharma Business senior vice-president and chief medical officer Salomon Azoulay said: "With this revised label, following consent from a healthcare professional and with proper training, UK women will now have the opportunity to administer Sayana Press outside of a clinical setting.
"This is an exciting milestone for women in the United Kingdom, and, potentially, in countries around the world, who might prefer this method of contraception and mode of administration."
According to Pfizer, Sayana should only be issued to girls aged 12 to 18 when other contraceptive methods are considered unsuitable.
The product is not yet approved for self-injection outside of the EU (EU), while the self-injectable method of administration is also approved or pending local approval in additional EU states, including Austria, Belgium, Hungary, Ireland, and the Netherlands.
Pfizer said that it will continue its efforts in bringing the updated label to additional markets globally, with an initial focus in Burkina Faso, Senegal and Uganda.
Injectable contraceptives are a widely-used family planning method, particularly among women in developing countries.
The company has advised that Sayana Press should not be used in women with known or suspected malignancy of the breast or genital organs, metabolic bone disease, or active thromboembolic disease.
Women with current or past history of cerebrovascular disease are also strong advised against using this contraceptive.
Last November, Pfizer, the Bill & Melinda Gates Foundation and the Children’s Investment Fund Foundation (CIFF) partnered to help broaden access to Sayana Press for women in need in 69 of the world’s poorest countries.
Under that deal, Sayana Press is being sold for $1 per dose to qualified purchasers, who help allow the poorest women in these countries to have access to the contraceptive at reduced or no cost.
Image: Pfizer world headquarters. Photo: courtesy of Jim.henderson.