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Positive Study Results Put Futura’s OTC Erectile Dysfunction Gel On Track For 2023 US Launch

 
• By David Ridley

Positive results from a confirmatory Phase III clinical study puts Futura Medical on track to file a dossier for drug-free erectile dysfunction gel MED3000 with the US Food and Drug Administration by the end of September 2022. This is in line with the company's timeline of approval as an OTC de novo medical device in Q1 2023.

US erectile dysfunction (ED) sufferers are one step closer to getting their hands on a drug-free OTC treatment after Futura Medical plc’s innovative MED3000 gel jumped another hurdle in the regulatory process.

Thanks to positive results from a confirmatory Phase III clinical study, FM71, which investigated the efficacy and safety of MED3000 gel in 96 male patients clinically diagnosed with a mix of mild, moderate, and severe ED, Futura is on track to file its dossier with the US Food and Drug Administration by

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People On The Move: Appointments At ANEPF, Inula, Opella

 
• By Tom Gallen

A round-up of the latest consumer health people moves: ANEFP elects president; Inula Group appoints CEO; Opella names ANZ head.

Over The Counter: Taking Real-World Evidence Seriously, With IQVIA Consumer Health’s Volker Spitzer

 
• By David Ridley

In part 2 of HBW Insight's interview, IQVIA Consumer Health's vice president of global research and development and real-world evidence services, Volker Spitzer, explains how to approach real world evidence so that regulators recognize its validity, in supporting Rx-to-OTC switch applications, for example.

Recordati Relying On OTC To Act As ‘Booster’ To Growth

 
• By Tom Gallen

In categories like cough & cold and gastrointestinal, OTC products have a pivotal role to play in helping Recordati hit its sales targets for the 2025-2027 period.

Bayer Consumer Health Delivers ‘Balanced’ Q1

 
• By Tom Gallen

With sales gains across most of its regions and product categories, Bayer Consumer Health got off to a good start to the year.

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People On The Move: Appointments at Opella, NèreS, Haleon

 
• By Tom Gallen

A round-up of the latest consumer health industry moves: Opella names France head; NèreS elects president; Haleon has new Saudi GM.

C&D Taps Hand Sanitizer Category With Touchland

 
• By Malcolm Spicer

Deal totaling as much as $880m extends C&D into additional product category with a brand it says is the fastest growing in the US hand sanitizer category and No. 2 brand in the category overall.

Venture Life Focuses On CHC As It Offloads CDMO

 
• By Tom Gallen

UK-based Venture Life is divesting its CDMO business and some non-core products to focus its attention on growing its consumer health operation.