FDA Events for Petros Pharmaceuticals (PTPI)
This section highlights FDA-related milestones and regulatory updates for drugs developed by Petros Pharmaceuticals (PTPI).
Over the past two years, Petros Pharmaceuticals has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
STENDRA. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
STENDRA (avanafil) - FDA Regulatory Timeline and Events
STENDRA (avanafil) is a drug developed by Petros Pharmaceuticals for the following indication: Erectile dysfunction (ED).
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- STENDRA (avanafil)
- Announced Date:
- September 11, 2024
- Indication:
- Erectile dysfunction (ED)
Announcement
Petros Pharmaceuticals announced results of an initial study to determine consumer comprehension of the messaging in its App Technology ("App Comp"), which has unique differences from the current Drug Facts Label ("DFL"). Of the 31 objectives, 29 scored >90% comprehension Point Estimate ("PE"), 30 scored >86.7% comprehension PE, and all scored >80% comprehension PE. 21 scored 100% comprehension PE.
AI Summary
Petros Pharmaceuticals announced promising findings from an initial study using its App Technology ("App Comp") to deliver medication information, which differs from the current Drug Facts Label ("DFL"). The study tested 31 distinct messages, finding that 29 objectives achieved over 90% comprehension, 30 achieved above 86.7%, and all reached more than 80% comprehension. Impressively, 21 of the objectives achieved 100% understanding. The study was conducted with consumers using both desktop and mobile devices to assess how well the new messaging is received. These results show that most communications were clearly understood by respondents, supporting the potential of the App Technology. Petros is now pursuing a larger-scale comprehension test with about 400 participants to confirm these results and ensure alignment with FDA standards. Results from the expanded study are expected by Q4 2024.
Read Announcement- Drug:
- STENDRA (avanafil)
- Announced Date:
- July 29, 2024
- Indication:
- Erectile dysfunction (ED)
Announcement
Petros Pharmaceuticals, Inc. announced results of a subsequent analysis of its pivotal study aimed at facilitating FDA-approved OTC access of the Company's STENDRA® (avanafil) for consumers.
AI Summary
Petros Pharmaceuticals, Inc. announced new results from an additional analysis of its pivotal study aimed at facilitating FDA-approved over‐the-counter access for STENDRA® (avanafil). The analysis focused on the effectiveness of the company’s proprietary Web App, which includes a clinically validated diagnostic questionnaire, in helping consumers accurately self-select the medication. The updated findings showed a point estimate of 94.9% and a lower bound of 91.51% for correct self-selection—improvements of 4.3% and 5.14% over earlier figures. These results indicate that users are more comfortable providing honest responses online, as opposed to during live interviews. Petros plans to present this evidence to the FDA, supporting its effort to achieve the first-ever prescription-to-OTC switch in the erectile dysfunction category.
Read Announcement- Drug:
- STENDRA (avanafil)
- Announced Date:
- July 16, 2024
- Indication:
- Erectile dysfunction (ED)
Announcement
Petros Pharmaceuticals, Inc. announces results of the first of a series of pivotal studies aimed at facilitating FDA-approved OTC access of STENDRA® (avanafil) for consumers.
AI Summary
Petros Pharmaceuticals, Inc. announced encouraging results from the first pivotal study aimed at supporting FDA-approved over‐the‐counter (OTC) access for its ED treatment, STENDRA® (avanafil). The study compared a new Web App Technology with the traditional Drug Facts Label (DFL) to help consumers decide if the medication was right for them. Results showed that 90.6% of participants using the Web App made the correct self-selection decision, compared to only 57.3% using the DFL alone. This significant improvement, especially among high-risk nitrate users, supports the company’s approach to meeting the FDA’s Additional Conditions for Nonprescription Use criteria. Petros is now working closely with the FDA and plans to conduct further pivotal tests, including an ‘actual use’ trial, as part of its pathway to switch STENDRA from prescription-only to OTC availability.
Read Announcement- Drug:
- STENDRA (avanafil)
- Announced Date:
- May 21, 2024
- Indication:
- Erectile dysfunction (ED)
Announcement
Petros Pharmaceuticals, Inc. announces it has formed an Advisory Committee to provide guidance as the company prepares for the potential Rx-to-OTC switch for STENDRA for both development and communication with the U.S. Food and Drug Administration.
AI Summary
Petros Pharmaceuticals, Inc. has formed an Advisory Committee to help guide its efforts as it prepares for the potential Rx-to-OTC switch for its flagship erectile dysfunction medication, STENDRA. This team, which includes former FDA officials and recognized clinical and regulatory experts, is tasked with shaping the development program and fine-tuning communication with the U.S. Food and Drug Administration. Its goal is to ensure that the study protocols, subject recruitment strategies, risk analyses, and related patient considerations meet the rigorous standards expected by the FDA.
The multi-disciplinary committee, comprising statisticians, clinical pharmacologists, and specialists in cardiology and urology, will provide critical insights that align Petros’ strategy with regulatory expectations. This proactive advisory collaboration is an essential step in helping the company potentially transition STENDRA to an over-the-counter status, expanding consumer access to the product.
Read Announcement- Drug:
- STENDRA (avanafil)
- Announced Date:
- April 23, 2024
- Indication:
- Erectile dysfunction (ED)
Announcement
Petros Pharmaceuticals, Inc. announces a new collaboration with Lemonaid Health, leading telemedicine provider and a subsidiary of 23andMe, serving hundreds of thousands of patients with quality healthcare.
AI Summary
Petros Pharmaceuticals, Inc. has announced a new collaboration with Lemonaid Health, a leading telemedicine provider and a subsidiary of 23andMe. This partnership will help expand the distribution of prescription STENDRA® (avanafil) for patients dealing with erectile dysfunction. Lemonaid Health, which serves hundreds of thousands of patients with quality healthcare across the United States, will now offer STENDRA on its online platform.
By working directly with Petros, Lemonaid Health will improve access to treatment through its 50-state licensed pharmacy network. This collaboration is expected to bring more discreet and efficient care to millions of men who need effective treatment for ED. Overall, the deal marks a significant step towards enhancing distribution channels and meeting patient needs in an innovative and accessible way.
Read Announcement- Drug:
- STENDRA (avanafil)
- Announced Date:
- April 16, 2024
- Indication:
- Erectile dysfunction (ED)
Announcement
Petros Pharmaceuticals, Inc. announces it has received positive feedback from the U.S. Food and Drug Administration (the "FDA," or the "Agency") following the FDA's informal review of Petros' technology component for self-selection as the Company endeavors to achieve OTC status for STENDRA.
AI Summary
Petros Pharmaceuticals, Inc. announced that it received positive feedback from the U.S. Food and Drug Administration after an informal review of its technology component for self-selection. This review is a key part of the company’s efforts to transition its erectile dysfunction treatment, STENDRA, to over-the-counter (OTC) status. The FDA acknowledged that the technology effectively addressed some concerns within the PDE5 inhibitor class, particularly for patients using nitrates. Company executives view this development as an important milestone on the path toward making STENDRA the first erectile dysfunction treatment in its class available OTC. Moving forward, Petros plans to incorporate the FDA’s guidance as it advances its development program, including further studies designed to confirm the technology’s effectiveness in ensuring proper self-selection by consumers.
Read Announcement
Petros Pharmaceuticals FDA Events - Frequently Asked Questions
As of now, Petros Pharmaceuticals (PTPI) has not received any FDA approvals for its therapy in the last two years.
In the past two years, Petros Pharmaceuticals (PTPI) has reported FDA regulatory activity for STENDRA (avanafil).
The most recent FDA-related event for Petros Pharmaceuticals occurred on September 11, 2024, involving STENDRA (avanafil). The update was categorized as "Results," with the company reporting: "Petros Pharmaceuticals announced results of an initial study to determine consumer comprehension of the messaging in its App Technology ("App Comp"), which has unique differences from the current Drug Facts Label ("DFL"). Of the 31 objectives, 29 scored >90% comprehension Point Estimate ("PE"), 30 scored >86.7% comprehension PE, and all scored >80% comprehension PE. 21 scored 100% comprehension PE."
Currently, Petros Pharmaceuticals has one therapy (STENDRA (avanafil)) targeting the following condition: Erectile dysfunction (ED).
More FDA Event Resources from MarketBeat
FDA Event Stage Terminology & Abbreviation Guide
- NDA: New Drug Application
- ANDA: Abbreviated New Drug Application
- sNDA: Supplemental New Drug Application
- BLA: Biologics License Application
- sBLA: Supplemental Biologics License Application
- FDA Approved: Approved by the FDA
- EMA: European Medicines Agency
- CE Mark: European Union Certification
- NMPA: China National Medical Products Administration
- MHLW: Japanese Ministry of Health
- FDA Meeting: Consultation with FDA
- Pre-IND: Pre-Investigational New Drug Meeting
- Breakthrough Therapy: Special FDA designation for promising therapies
- Fast Track: Accelerated FDA approval pathway
- Orphan Drug: Designation for rare disease treatments
- RPD: Rare Pediatric Disease Designation
- RMAT: Regenerative Medicine Advanced Therapy
- DSMB Review: Data Safety Monitoring Board Review
- IDMC Review: Independent Data Monitoring Committee
- MAA: MHRA Marketing Authorization Application
- RTF: Refusal to File (Rejected Application)
- 510(k): FDA Clearance for Medical Devices
- Rolling Submission: Staggered regulatory review process
This page (NASDAQ:PTPI) was last updated on 7/11/2025 by MarketBeat.com Staff
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