Contraceptive alternatives – Mayne Pharma receives FDA response putting them a step closer to approval

Of the myriad of contraceptives out there, those that don’t require daily effort are gaining in popularity. As our lives get busier and brains get fuller, women are electing for long term, ‘set and forget’ birth control measures.

Two thirds of Australian women of reproductive age use birth control. Whilst methods like the oral contraceptive pill and condom use are the most popular, studies suggest that these may not be as effective as some of the long-acting, reversible contraceptives. This is primarily due to human error resulting in imperfect usage- think forgetting to take the pill before you rush out of the house in the morning.

Whilst not as popular as oral contraceptives, vaginal rings are an effective method of contraception (more than 99%!) and one ring provides protection for a month. The ring is made from soft plastic and contains two types of hormones- an oestrogen and a progestogen. These hormones released from the ring prevent the ovulation, stopping the ovaries from releasing an egg.

Specialty pharmaceutical company, Mayne Pharma (ASX: MYX), in partnership with women’s health specialists Mithra, are working to commercialise a generic version of the vaginal ring. The Company has received a complete response letter from the US Food and Drug Administration (FDA) following their application for approval.

The abbreviated new drug application lodged by Mayne Pharma will hopefully see the generic vaginal ring joining their lengthy generics catalog. Both Mayne and Mithra will now work together to address queries raised by the FDA in their response letter. Once addressed, the companies will issue a response to the FDA and receive a new target action date.

Mayne Pharma’s CEO Scott Richards commented on the new developments, saying: “We are now one step closer to approval and are confident that we can address the few remaining outstanding questions raised by the FDA in a timely manner. Pleasingly, the FDA has no questions around Mithra’s facility, the drug product manufacturing process, drug substance of bioequivalence. The market opportunity continues to be attractive with two independent generics approved and an addressable market of US$670m.”