FDA Lifts Clinical Hold on Opella's Cialis OTC Switch Trial
Key Insights
The FDA has lifted the clinical hold on Opella (search)'s actual use trial (AUT) for Cialis, supporting its potential switch to an over-the-counter (OTC) medication.
This decision marks Cialis as the first PDE-5 (search) inhibitor to reach this milestone, paving the way for a new self-care solution for erectile dysfunction (search).
The AUT will evaluate Cialis's use under real-world conditions, ensuring consumers can self-diagnose and treat appropriately without medical supervision.
The FDA has lifted the clinical hold on Opella (search)'s actual use trial (AUT) for Cialis (tadalafil), a significant step toward making the erectile dysfunction (search) (ED) drug available over-the-counter (OTC) in the United States. This decision marks Cialis as the first phosphodiesterase 5 (PDE-5 (search)) inhibitor to reach this milestone, potentially expanding access to a proven treatment for ED.
Actual Use Trial Details
AUTs are designed to evaluate how consumers use a medicine in real-world conditions, ensuring they can self-diagnose and treat their condition appropriately without the guidance of a healthcare provider. The trial aims to identify any previously unidentified issues and confirm the safety and efficacy of Cialis for OTC use.
Julie Van Ongevalle, President and CEO of Opella (search), stated, "The actual use trial is not only a significant opportunity to gain insights into how Cialis is used by consumers without a prescription, but it also underscores our commitment to advancing self-care solutions."
Cialis: Current Use and Benefits
Currently, Cialis is available in the US only with a prescription. It is used to treat erectile dysfunction (search) (ED), the signs and symptoms of benign prostatic hyperplasia (search) (BPH), and both conditions simultaneously. Cialis offers men a choice in treatment options, including on-demand and once-daily use.
Safety Information
Cialis is not intended for use by women or children. It should not be taken with nitrates, such as isosorbide dinitrate or isosorbide mononitrate, often prescribed for chest pain, or with recreational drugs called poppers, like amyl or butyl nitrite, as this combination may cause a dangerous drop in blood pressure. Individuals allergic to Cialis or Adcirca (tadalafil) or any of their ingredients should also avoid it.
Opella's Commitment
Opella (search) remains dedicated to advancing its development program and providing a new self-care solution with proven effectiveness for people living with erectile dysfunction (search). The company is completing the clinical and regulatory activities necessary to initiate the pivotal AUT, with study information to be available on clinicaltrials.gov.
Dr. Josephine Fubara, Chief Science Officer at Opella (search), noted, "FDA’s decision marks a significant step forward in Opella’s data-driven efforts to switch a PDE-5 (search) inhibitor like Cialis... We look forward to continuing our work to bring safe and expanded access to the many consumers who will benefit from nonprescription Cialis."