Sexual health OTC revolution

Building on the news covered in last week’s blog that Sanofi is planning to implement the US Rx-to-OTC switch of erectile dysfunction treatment Cialis by end-2024, this week we look at another major development in the OTC sexual health & fertility category – the announcement by the UK’s MHRA that it has launched a public consultation on the reclassification of two progestogen-only contraceptive pills containing desogestrel, marking the first time the agency has considered such a change.

MHRA is asking the public and stakeholders for their views on whether two continuous-use oral contraceptives – HRA Pharma’s Hana and Maxwellia’s Lovima, both as 75mcg film-coated tablets in 28-count packs – should become pharmacy medicines and available OTC, without a medical prescription (although, in parallel, desogestrel 75mcg will also remain available on prescription, with women potentially able to switch between prescription or pharmacy supply at different times). The agency notes that if the products are reclassified, pharmacists will have access to training materials and a checklist to help them to identify women who can receive the two medicines safely. Two separate consultations are open until 5th March (Hana link; Lovima link).

Following the switch of Adamed’s Maxon Forte (sildenafil 50mg) in Poland in early 2020, the rollout of OTC Viagra (Viatris) to Norway and Ireland in 2020, plus the EU centralised Rx-to-OTC switch of Fortacin (Recordati for Plethora Solutions) for premature ejaculation – formulated with lidocaine 150mg + prilocaine 50mg – in September 2020, the past year has seen a rapid expansion in the availability of OTC sexual health & fertility medicines. With OTC ED on the near horizon in the US market, the UK approval of the daily contraceptive pill as an OTC medicine could lead to a wave of similar approvals worldwide, and inject substantial growth into the global CHC market over the coming years.

CHC.NewDirections Consulting Editor, Nina Stimson adds: This really is an exciting proposal – not only a first for the UK, but also the first significant bid to offer oral contraceptives without prescription outside the Asia Pacific region – China and South East Asian markets lead the way, although sales in most markets are relatively small. If the proposal is approved, will UK pharmacists actively support the switch and help build OTC supply (and will the pharmacy protocol be sufficiently user-friendly not to push women back to the doctor)? And will any price differential between Rx or OTC supply be a factor? Not all ambitious switches in the UK have succeeded in the past, but we have high hopes for this one. Time will tell …

You can save up to GB£1,350 when you pre-order our forthcoming report from CHC New Products Tracker, Innovation in CHC: 2020’s NPD & Launch activity under the spotlight before 31st March! As well as looking in more depth at the latest OTC sexual health & fertility developments, the report also showcases the top 100 innovations in 2020 and features major ingredient trends, delivery format trends and much more. For more information, or to pre-order your copy, please contact melissa.lee@NicholasHall.com.

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