Petros Pharmaceuticals

Petros Pharmaceuticals Advances STENDRA OTC Bid with Positive FDA Feedback


Petros Pharmaceuticals, Inc. has taken a significant step toward making its erectile dysfunction drug, STENDRA, available over-the-counter (OTC), following constructive feedback from the U.S. Food and Drug Administration (FDA).

During a recent Type C meeting, the FDA reviewed Petros’ innovative technology for self-selection, crucial for ensuring the safe use of STENDRA by consumers, particularly those using nitrates. Fady Boctor, Petros’ President and Chief Commercial Officer, expressed optimism about the meeting’s outcomes, highlighting the potential to meet an unmet medical need in the ED market.

The FDA’s feedback has been instrumental in refining the company’s approach, especially concerning the drug’s self-selection process for consumers. This is part of a broader regulatory pathway that includes the development of a consumer-friendly Drug Facts Label (DFL) and rigorous consumer testing through various studies like the Self-Selection Study and Application Comprehension Study.

A Unique Drug In The ED Market, Understanding STENDRA

STENDRA, known chemically as avanafil, is a medication approved by the FDA in 2012 for the treatment of erectile dysfunction (ED). It belongs to a class of drugs known as phosphodiesterase 5 (PDE5) inhibitors, which work by increasing blood flow to the penis to help achieve and maintain an erection. Avanafil is effective when taken in conjunction with sexual stimulation.

The drug was originally developed by Mitsubishi Tanabe Pharma and later licensed to Vivus Inc., which commercializes it under the brand names STENDRA in the US and Spedra in Europe and other regions. This medication is known for its rapid onset of action, allowing it to be taken as little as 15 minutes before sexual activity. Avanafil is available in dosages of 50 mg, 100 mg, and 200 mg, with 100 mg being the typical starting dose.

STENDRA is generally well-tolerated, but it can cause side effects similar to other PDE5 inhibitors, such as headaches, flushing, nasal congestion, and back pain. More serious side effects can include prolonged erections, sudden vision loss, and hearing changes. Due to its effects on blood pressure, it should not be taken with nitrates or certain other medications like alpha-blockers, which are used to treat high blood pressure or prostate conditions, as this can lead to a dangerous drop in blood pressure.

STENDRA is unique among erectile dysfunction treatments due to its quick action and the ability to take it with or without food, though high-fat meals might delay its effectiveness.

Erectile Dysfunction Drug Total Market Size & STENDRA Potential

The global market for erectile dysfunction drugs is experiencing steady growth and is projected to continue expanding over the coming years. As of 2024, the market is expected to reach approximately $4.17 billion, with a slight growth forecast at a compound annual growth rate (CAGR) of about 1.2% leading up to 2024​. By 2030, this market is anticipated to grow further to around $6.5 billion, driven by a CAGR of 8.5%​.

Several factors contribute to this growth, including an aging population, increased prevalence of chronic diseases like diabetes and cardiovascular conditions which are linked to erectile dysfunction, and evolving consumer attitudes towards sexual health and medication. The transition of erectile dysfunction drugs from prescription to over-the-counter (OTC) status can significantly impact public health by increasing access and reducing the stigma associated with these medications.

Moreover, the market dynamics indicate a significant shift towards online pharmacies, which are expected to see substantial growth due to their convenience and privacy, helping reduce the stigma associated with purchasing these drugs​. This shift is also supported by an increase in telemedicine, which has become a popular platform for managing erectile dysfunction, especially highlighted during the COVID-19 pandemic when many patients turned to online consultations.

The move towards OTC availability of drugs like STENDRA, as pursued by companies like Petros Pharmaceuticals, aligns with these trends, potentially pioneering a new direction for erectile dysfunction treatment accessibility and management in the healthcare industry.

Petros Pharmaceuticals, Focused on Men’s Health

Petros Pharmaceuticals, Inc. is a biopharmaceutical company primarily focused on addressing men’s health issues. Established from the merger of Metuchen Pharmaceuticals and Neurotrope, Petros aims to lead in the market of FDA-approved treatments for men’s health conditions, which are often underserved. This strategic alignment has enabled Petros to enhance its portfolio and market presence significantly​.

Petros Pharmaceuticals is actively engaged in developing and commercializing products for erectile dysfunction and Peyronie’s disease, among other men’s health issues. Their flagship product, STENDRA (avanafil), is an erectile dysfunction medication that stands out in the market for its distinct molecular formulation. Additionally, the company is exploring the development of H-100, a novel and patented topical formulation for acute Peyronie’s disease, currently in early clinical testing.

The company’s broader strategy includes a strong emphasis on innovation and market expansion through research and development in various areas of men’s health, including sexual dysfunction and related conditions. This is part of their long-term vision to provide comprehensive solutions that address multiple aspects of men’s health, supporting both physical and psychological well-being​.

What’s Next for STENDRA

With the FDA’s guidance, Petros Pharmaceuticals continues to pave the way for STENDRA to potentially become the first erectile dysfunction medication available OTC. This move could transform access to treatment for many individuals and set a precedent for other drugs in this class.

For ongoing updates on STENDRA’s OTC journey and Petros Pharmaceuticals’ innovations, follow our detailed coverage.

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