Poland’s Adamed Secures Tadalafil Rx-To-OTC Switch In World First
Executive Summary
Poland becomes the first country in the world to allow erectile dysfunction treatment tadalafil to be bought without a prescription thanks to a successful Rx-to-OTC switch application from local player Adamed Pharma.
Polish firm Adamed Pharma has become the first company in the world to switch erectile dysfunction drug tadalafil from prescription to OTC status.
At the beginning of February, the president of Poland’s Office for Registration of Medicinal Products, Medical Devices and Biocidal Products issued a decision to make Adamed’s Tadalafil MaxOn (10mg) treatment available OTC.
The switch was approved on the basis of a successful study conducted by Adamed to confirm the safe use of the drug by consumers without the intervention of a doctor.
“The results obtained clearly indicate that the patient, without consulting a doctor, using a specially developed diagnostic tool (in the form of an attached questionnaire) is able to make an independent and safe decision regarding the possibility of using tadalafil,” the firm said.
The use of this tool is necessary before taking the drug, it added.
ED Strategy
Speaking exclusively to HBW Insight, Adamed said that the purpose of the switch, along with the firm’s other interventions in Poland’s ED category, is to “provide men with a convenient solution of proven efficacy for their sexual health therapeutic needs.”
In 2016, Adamed was the first company to launch an OTC sildenafil product to the Polish market, and in 2020 it launched a 50mg non-prescription version of the drug.
“Tadalafil MaxOn joins the Maxon brand this year offering a new market proposition for patients who especially appreciate spontaneity in their sexual life,” Adamed said.
Highlighting the differences between tadalafl and sildenafil, Adamed said that the former has a “longer time of action (works up to 36 hours) than the latter and is influenced neither by food nor alcohol.
Sildenafil starts working 30 to 60 minutes after administration, the firm explained. “Its effectiveness is lower after a heavy, fatty meal due to prolonged absorption.”
Tadalafil, on the other hand, is effective 30 minutes after administration, it continued, with “peak effectiveness” after approximately two hours. “The effectiveness lasts up to 36 hours,” it added, “and consumed meals do not interact with it.”
Tadalafil is also effective in difficult-to-treat cases, for example diabetes, and is safe in patients with circulatory disorders, as it does not exacerbate incidents of this system, Adamed noted.
Sildenafil Switches Stack Up
While Poland has now become the first and only country to allow tadalafil to be sold OTC, sildenafil is becoming more widely available in many markets across the world.
The UK was first to reclassify Viatris' Viagra at the end of 2017 with Norway following in 2019, approving the switch of the drug under the brand name Viagra Reseptfri. (Also see "Pfizer Building Viagra As Pan-European Consumer Health Brand With Rx-To-OTC Switch In Norway" - HBW Insight, 28 Aug, 2019.)
The UK’s sildenafil market is becoming increasingly competitive, with Perrigo, Teva and Dr Reddy’s all launching Viagra alternatives in recent months.
Germany's Expert Committee on Prescription, meanwhile, recently voted by majority to retain the prescription requirement for sildenafil (50mg, oral use). (Also see "No OTC Sildenafil In Germany After Committee Rejects All Rx-To-OTC Switches" - HBW Insight, 28 Jan, 2022.)
Across the Atlantic, Viatris is yet to seek US Food and Drug Administration approval for a Viagra switch, however its consumer health competitor Sanofi is hoping to reclassify its tadalafil-based ED treatment Cialis. (Also see "Sanofi Counts On OTC Switches Adding $1bn In Consumer Revenues By 2026" - HBW Insight, 11 Dec, 2019.)
Sanofi Seeking Tadalafil Switch
Sanofi Consumer Healthcare boss Julie Van Ongevalle told analysts during the firm’s latest earnings call that its plan to switch Cialis “continues to progress despite the pandemic.” (Also see "Sanofi Not Distracted By M&A Chatter As It Gets Back On Par With Market Growth" - HBW Insight, 7 Feb, 2022.)
“The team is actively working on the projects, and we continue to execute critical studies in an accelerated fashion,” she said. “For Cialis, we have completed the self-selection studies and results have been submitted to FDA along with the protocol for an actual use trial. We are now waiting for the FDA feedback in order to proceed.”
Sanofi hopes to launch OTC Cialis by 2026, and believes the product, along with the proposed switch of flu remedy Tamiflu, could add $1bn in sales. (Also see "Sanofi Counts On OTC Switches Adding $1bn In Consumer Revenues By 2026" - HBW Insight, 11 Dec, 2019.)
Another ED option may soon also become available OTC in the US, with Petros Pharmaceuticals looking into switching its avanafil-based Stendra treatment. (Also see "Petros Includes Nitrate Patients In OTC ED Drug Self-Selection Studies" - HBW Insight, 20 Jan, 2022.)