Rx-to-OTC Switch
“Overall, no unexpected/new data or findings” were presented to Germany's Expert Committee for Prescription in the most recent Rx-to-OTC switch application for sildenafil (25mg and 50mg), according to medicines regulator BfArM, resulting in a third rejection in three years.
HBW Insight catches up with Maxwellia CEO Anna Maxwell to discuss her company's journey so far, and what she sees as the opportunities for Rx-to-OTC switch in UK women's health and beyond.
Advercheck managing director James Walmsley talks to HBW Insight about the challenges facing consumer health companies today as they move away from the prescription medicines sector and its pipeline of switchable ingredients towards self-care and prevention.
Almost two thirds (62%) of respondents to an online survey said they would rather buy non-prescription medicines in a local pharmacy than via a mail-order pharmacy, Pharma Deutschland reports.
Sleep, pain, allergy and women's intimate health among the categories that the UK Department of Health and Social Care would like to see manufacturers submit Rx-to-OTC switch applications for.
Increased openness about sexual health and wellness, Rx-to-OTC switches and NPD at leading companies, and easy access to products online are driving the growth of Europe's sexual health market, according to Euromonitor International.
“The SVA has missed an opportunity to make an important contribution to patient safety and to strengthening personal responsibility,” commented Pharma Deutschland deputy general manager Elmar Kroth.
Opella says FDA “lifted a clinical hold on its planned actual use trial to support the switch of Cialis” while Petros Pharmaceuticals shifts from working on its own ED-switch proposals to developing a proprietary technology-assisted platform designed for use in consumers’ self-selection of drugs made available in ACNU proposals.
Today, Germany's switch committee, the SVA, will consider an application for exemption from requirement for sildenafil in 25mg and 50mg strengths. This is the third time the switch has been put to the committee, which has rejected it twice before.
Australian government finds an insufficient body of new evidence to support Rx-to-OTC switch of erectile dysfunction drug sildenafil since it was last considered in 2020.
Final rule’s requirement that ACNU formulations also remain available as Rx generics could limit revenues for marketers of the nonprescription drugs while approvals of ACNU applications from studies with participants having drugs delivered to their homes may require marketers to limit distribution to direct-to-consumer without clearance for sales in retail stores.
Study completed in 2024 showed consumers using an online application accurately self-selected and safely used an Rx statin drug. An “ACNU” switch NDA would have to first show conventional OTC labeling won’t support proper self-selection and use.
Agency’s proposal for targeting making more formulations available nonprescription through “novel switches” went through changes on its path from idea in 2012 to proposed rule in 2022 and final rule published in December.
FDA’s ‘ACNU’ rule went through numerous twists and turns from agency’s “new paradigm” idea of OTC switches in 2012 to publication.
Oral pseudoephedrine decongestants marketed by Kenuve, Haleon and Opella, amongst others, are now only available with a doctor's prescription in France.
OTC antifungal fluconazole will soon only be available with a doctor's prescription in Norway.
Consumers in Denmark no longer need a prescription to buy opioid antagonist naloxone as the country looks to tackle the growing issue of overdose.
FDA’s OTC office director details a 2023 guidance as opening doors for NRT innovation at recent public meeting, but researchers and an industry executive note the most recent approval in the US for an innovative NRT was more than 20 years ago and say FDA isn’t allowing sufficient flexibility for approvals of new products or indications other than cessation related to quitting smoking.
Even at conservative estimates, switching an additional 97 molecules could save about €200m, according to France's consumer health industry association.