Rx-to-OTC switch round-up

Following our recent blogs on Sanofi’s plans to switch erectile dysfunction treatment Cialis and flu antiviral Tamiflu to OTC status in the USA within the next three years, and the UK MHRA announcement it has launched a public consultation on the reclassification of two progestogen-only contraceptive pills containing desogestrel, here we round up other recent OTC switch developments from around the world (Japan, Russia, China and Argentina).

In Japan, a panel under the Ministry of Health, Labour & Welfare’s Pharmaceutical Affairs & Food Sanitation Council has approved the switch from Rx to OTC (Instruction-Required Drugs with 3-year post-marketing surveillance period) of the following products:

  • Kobayashi’s Ira-Kuna contains itopride hydrochloride for the treatment of gastrointestinal symptoms (e.g. bloating and heartburn)
  • BUP-4 Lady Yuli-less (Taiho / Otsuka) formulated with propiverine hydrochloride 10mg (half the dosage of Rx versions) for urinary problems caused by overactive bladder
  • Nasivin Medi an oxymetazoline hydrochloride + chlorphenamine maleate nasal spray for rhinitis. Sato launched Japan’s first OTC oxymetazoline nasal spray, Nasivin M Spray, in April 2011 (then a Merck-owned brand, now P&G)

The Rx-to OTC switches of itopride hydrochloride and propiverine hydrochloride were approved in 2018, but this is the first time that products containing these ingredients have been approved for OTC sale.

Source: CHC New Products Tracker

In China, the NMPA has approved the Rx-to-OTC switch of miconazole nitrate 0.1g tablets for vaginal use. Relevant marketers must provide revised package inserts to health authorities by 1st December 2021. Companies that market this formulation Rx include China Resources Double Crane and Yun Shin Pharm.

In Russia, Janssen (J&J), Bayer and RB are among the companies behind the creation of the Association of Healthcare Product Manufacturers, which is designed to promote responsible self-medication in Russia and form an adequate regulatory framework regarding the availability of OTCs, medical devices and supplements. This includes shortening the registration time for well-established ingredients with proven safety and efficacy, and creating clear criteria for Rx-to-OTC switch activity.

And finally, in Argentina, Elea has extended women’s health brand Eva with EvaCare Gyno capsules (fluconazole 150mg) – Argentina’s first OTC oral VYI treatment. A TV A+P campaign highlights its convenient format – “1 capsule, 1 dose, 1 day” – for treating the symptoms of vaginal candidiasis. The product will compete with clotrimazole-based Empecid Gyno (Bayer; GynoCanesten globally) and Lomecan V (Genomma) creams and vaginal ovules.

Review case studies of successful Switches in our forthcoming report from Nicholas Hall’s CIMA team, written in association with switch expert Joe McGovern of Biograph Inc. Pre-order your copy of Rx-to-OTC Switch: A Hot Topic Report before 31st March to save with our pre-publication discount! For more information, or to purchase your copy, please contact melissa.lee@NicholasHall.com.

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