Rx-to-OTC switch: Fortacin in EU, CBD in Australia

Rx-to-OTC switch activity has shown signs of revival so far in 2020, and two more positive news stories emerged last week. First, the European Commission has approved the Rx-to-OTC switch of Fortacin topical spray for premature release in adult men (owned by Plethora Solutions and marketed under licence by Recordati; lidocaine 150mg/ml + prilocaine 50mg/ml), following the July 2020 recommendation from the EMA’s Committee for Medicinal Products for Human Use. Recordati will reportedly begin the OTC launch of Fortacin in January 2021. This is the fifth brand to receive switch approval via the EU centralised procedure, and the first since 2015 when ellaOne (HRA Pharma) was given the rubber stamp.

Secondly, a delegate of the Secretary to Australia’s Department of Health has released an interim recommendation to switch plant-derived or synthetic CBD ≤60mg (up to 30 days’ supply, adults aged 18+ years) from Rx to Schedule 3 (Pharmacist-only), with a proposed implementation date of 1st June 2021. The ingredient will also be added to Appendix M of the Poisons Standard, with supply limited to medicines registered on the Australian Registry of Therapeutic Goods.

Source: CHC New Products Tracker

Comments are being sought until 13th October 2020 on this proposed CBD switch in Australia, as well as the following recommendations:

  • Switch migraine treatment eletriptan ≤40mg (up to two tablets) from Rx to S3 and include the ingredient in Appendix H to permit consumer A+P (1st February 2021)
  • Permit the S2 (Pharmacy-only) sale of immediate-release ibuprofen ≤400mg (up to 12 dosage units) when labelled not for children under 12 years (1st February 2021)
  • Do not switch sildenafil 50mg (up to four dosage units) from Rx to S3 and include the ingredient in Appendix H and Appendix M
  • Do not permit general sale of oxymetazoline ≤0.05% nasal sprays
  • Do not permit the S2 sale of clotrimazole ≤1% preparations for vaginal use

One of the key reasons behind the TGA’s establishing Appendix M in January 2018 was to facilitate future switch activity by helping ingredients meet the S3 Scheduling Policy Framework criteria through the provision of additional pharmacist controls or supply requirements. This channel has had some success, with CBD appearing to be the latest ingredient to benefit. Some stakeholders had also hoped that additional controls would finally sway opinion on the OTC availability of ED medicines but the scheduling delegate did not think the risk mitigation strategies outlined in the Appendix M entry assessed the risks associated with sildenafil use.

Nicholas Hall Writes: Last week I presented the key conclusions from last year’s New Paradigms report and my client asked, what will be the really high growth categories in the post-Covid CHC market? That is a really good question, and it seems to me that there are six emerging sectors each with sales potential of over US$10bn at MSP:

  1. CBD
  2. Sexual health
  3. Sleep, stress & mood
  4. Food allergy & intolerance
  5. Probiotics
  6. Immunity

Each of these presents opportunities, each of these presents formidable obstacles. In the case of CBD, the major hurdle is regulatory. So if this news from Australia is borne out, and CBD becomes a registered OTC category — the first in the world — we will have overcome the first barrier in the long journey to regulate and regularise this awesome opportunity, and I use the word awesome in its original sense, not as a teenage throwaway remark!

Don’t miss out on your chance to save up to GB£1,800 when you pre-order our upcoming report, Cough, Cold & Allergy before 30 September! For more information, or to pre-order your copy, please contact melissa.lee@NicholasHall.com.

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