One of the factors contributing to lower global consumer healthcare growth in recent years has been a falling-off in Rx-to-OTC switch activity in key markets like Japan and the USA. Looking ahead, however, there are reasons to be positive. In December 2019, Sanofi CEO Paul Hudson cited the company’s “plans to accelerate the over-the-counter switches for Cialis and Tamiflu” in order to fulfil its ambition of growing faster than the CHC market over the mid-term. In light of the current coronavirus epidemic, the benefits of wider OTC access to flu remedies is all the more evident.
Sexual health is another category with huge Rx-to-OTC switch potential, notably erectile dysfunction medicines and daily oral contraceptives. Though the switch of Cialis (tadalafil) has been stuck at the FDA for several years now since its submission, sildenafil (Viagra) is enjoying ever wider OTC availability, especially in Europe. After switching in Poland in 2016, sildenafil was launched as Viagra Connect (Pfizer) in the UK in 2018 and will be launched OTC as Viagra Reseptfri in Norwegian pharmacies in early 2020.
There is also renewed interest in OTC triptans for migraine. A handful of switches took place in the mid-2000s but were held back by OTC purchase limits (a 2-tablet emergency pack). Over the past year, various countries have again began discussing triptan switches including Australia, Ireland and Germany (which is expected to expand the number of triptan molecules in the OTC sector), though major expansion of the segment is unlikely without larger pack sizes.
All that said, reverse-switch remains a threat and one OTC ingredient of ongoing concern is codeine. In late 2019, New Zealand’s Medicines Classification Committee, following Australia’s lead, recommended that all codeine-containing medicines should be reverse-switched from OTC to Rx. In January 2020, citing “widespread concern about the abuse of codeine-containing preparations nationally and globally”, the South African Health Products Regulatory Authority said it is reviewing the scheduling status of codeine and codeine-containing medicines which are available without a prescription.
CHC.NewDirections is an e-newsletter sent every Tuesday, with a focus on innovation, science and regulation. Coverage spans Rx-to-OTC switch, CBD, relevant medical research, probiotics, medical devices and new delivery formats, digital health / AI, e-cigarettes and much more! For more information, or to arrange a free trial, please contact Melissa.Lee@NicholasHall.com