A progestogen-only form of emergency contraception has been licensed as a prescription only medicine (POM). Levonelle-2 tablets contain levonorgestrel 750mcg. A spokesperson for Schering Health Care, the company marketing the product, told The Journal on December 14 that it would be launched within the first quarter of next year and hopefully by February.
The company says that a pharmacy (P) licence for the product may be considered in the future but that a period of distribution as a POM is important to gain experience of the product to establish whether wider availability would be appropriate. Discussions to assess the social implications, training and resource requirements of pharmacists and patient acceptance of direct access through pharmacies have to continue, says Schering.
Schering says that Levonelle-2 compares favourably with Schering PC4, the form of emergency contraception currently marketed, which contains both oestrogen and progestogen. It notes that a World Health Organisation trial found progestogen-only emergency contraception to be more effective and better tolerated, causing less nausea and vomiting, than the oestrogen and progestogen-containing formulation. Schering comments that it was because of the improved side effect profile of progestogen-only emergency contraception that a P licence for the product can be considered.
Levonelle-2 consists of two tablets, which each contain 750mg levonorgestrel. One tablet (rather than two as for PC4) should be taken as soon as possible after unprotected sex and the other 12 hours after the first dose.
Despite the advantages of Levonelle-2, Schering says that PC4 will continue to be marketed as it will remain useful for prescribers who currently use it and do not wish to swap to a new therapy.
Schering has secured distribution rights for Levonelle-2 in the UK from Gedeon Richter, a Hungarian company, and its UK subsidiary and licence holder Medimpex UK Ltd.
A levonorgestrel-only emergency contraceptive, Norlevo, is marketed in France by HRA Pharma. A spokesman for the company told The Journal on December 14 that an application for a pharmacy licence for the product was under way and it hoped to gain European licensing approval in the first quarter of 2000.
Commenting on the licensing of Levonelle-2, the President of the Royal Pharmaceutical Society, Mrs Christine Glover, said that the Society "welcomed the recognition that this new product could be supplied appropriately from pharmacies, which will help women gain quicker and easier access to a safe and effective method of emergency contraception". She added that the Society was working to ensure that pharmacists had the training they needed to supply emergency contraception without a prescription in the future.
"We know that our profession wants to be involved in the important public health issue of sexual health and contraceptive care. Our Code of Ethics allows pharmacists to follow their own conscience in such matters, while ensuring that patients have access to pharmaceutical services," she said.
Levonelle-2, Schering’s progestogen-only form of emergency contraception, contains 750 micrograms of levonorgestrel and not 750mg as previously stated