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Petros Includes Nitrate Patients In OTC ED Drug Self-Selection Studies

 
• By Malcolm Spicer

Firms also notes in its announcement that FDA typically requires actual use trials for switch NDAs in addition to label comprehension studies, which it has conducted, and self-selection studies.

• Source: Alamy

Self-selection studies starting for Petros Pharmaceuticals Inc.’s erectile dysfunction drug Stendra (avanafil), one with men also using nitrate medicines, could be pivotal to the US Food and Drug Administration’s potential reception for the firm’s planned OTC switch proposal.

“This is an important next step in the development plan to seek non-prescription status for Stendra and will inform whether...

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More from Rx-to-OTC Switch

Haleon Study: Self-Care Policies Could Save Finland €60m Per Year

 
• By David Ridley

Creating a working group to drive Rx-to-OTC switch is one of the ways in which Finland could expand self-care and save €60m per year for the country's health system, suggests a recently published report commissioned by Haleon.

PAGB: UK Gov Must Invest In Self-Care To Realize ‘Untapped Potential’

 
• By David Ridley

Reacting to chancellor Rachel Reeves' 2025 public spending review, PAGB welcomed increased funding for healthcare and life sciences while stressing the need to promote self-care practices.

EU Pharma Reform: Council Proposes Rx Exemption For Topical Antimicrobials

 
• By David Ridley

The EU Council has introduced a key amendment to Article 51 (para 1, point e) of the new pharma directive: “A medicinal product shall be subject to medical prescription where it is an antimicrobial, unless intended for topical use.”

AESGP Annual Meeting: Commission Must ‘Think Carefully’ Before Reverse-Switching Antimicrobials

 
• By David Ridley

If the European Commission is serious about improving the competitiveness of the European Union, it should ditch the idea of making commonly used OTC antimicrobials like thrush treatments and cold sore creams prescription-only, warns Greek Medicines Agency president Evangelos Manolopoulos

More from Health

People On The Move: Appointments At Pharma Deutschland, AMA, FSA

 
• By Tom Gallen

A round-up of the latest people moves: Pharma Deutschland names head of new OTC Market division; the African Medicines Agency appoints director general; the UK's Food Standards Agency adds members to novel foods committee.

Haleon Study: Self-Care Policies Could Save Finland €60m Per Year

 
• By David Ridley

Creating a working group to drive Rx-to-OTC switch is one of the ways in which Finland could expand self-care and save €60m per year for the country's health system, suggests a recently published report commissioned by Haleon.

Moberg Nail Fungus Line Takes Lead In Norway As Firm Plots EU Expansion

 
• By Tom Gallen

Terclara - Moberg’s proprietary topical formulation of terbinafine for fungal nail - has established itself as the market leader in Norway just months after its OTC launch. The firm is now plotting its expansion to additional EU markets.