The Challenge
Seeking to improve the quality of a person's life by minimizing barriers to success and daily commitments.
Seeking Solutions
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PP-01 is being developed as an oral prescription medication and has completed Phase 2.
In addition to PP-01, we are looking for alternative solutions for other unmet needs for substance use disorders.
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Our Pipeline
Expanded Access and Compassionate Use
PleoPharma, Inc. (PleoPharma) is committed to developing safe and effective medicines to transform the lives of patients who are suffering from cannabis related harms. A proprietary product is being developed to mitigate cannabis withdrawal symptoms in adolescents and adults with cannabis use disorder (CUD). Our goal is to provide access to our investigational drug at the appropriate time and in the safest manner for patients. We are currently in product development, and the route to marketing approval for investigational drugs requires conducting multiple clinical trials.
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A clinical trial is a research program conducted with patients to evaluate an investigational new drug (IND) in which comprehensive safety and efficacy data are compiled. PleoPharma believes that participation in our clinical trial is the most appropriate way to access our investigational drugs, consistent with U.S. Food and Drug Administration (FDA) recommendation: “Whenever possible, an investigational medical product should be used as part of a clinical trial.”
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Expanded access, sometimes called compassionate use, refers to the use of an investigational new drug outside of a clinical trial for patients with serious or life threatening conditions who have exhausted their treatment options and are not eligible for or able to participate in a clinical trial.
Treating physicians and patients should note that investigational drugs do not have established safety and efficacy and have not yet been approved by the FDA for their specific use(s); therefore, it is important to understand and carefully evaluate all potential risks and benefits before seeking expanded access to unapproved medicines.
At this time, PleoPharma does not offer an Expanded Access Program and does not accept requests for expanded access to its investigational product. Participation in a company-sponsored clinical trial is currently the only way to access PleoPharma investigational product. We encourage physicians and patients interested in our investigational product to learn more about our ongoing studies by visiting clinicaltrials.gov and searching for PleoPharma. If you are a physician interested in learning more about our investigational product or participating in our clinical trials, please submit a request to MedInfo@PleoPharma.com.
Commitment to Patients
We recognize that some patients and caregivers may seek investigational therapies due to serious or life‑threatening illness and limited treatment options. While we are not currently able to provide expanded access, PleoPharma is committed to:
• Advancing its investigational programs as efficiently and responsibly as possible
• Conducting well‑controlled clinical trials designed to support regulatory approval
• Making therapies broadly available to patients if and when they are approved by regulatory authorities
PleoPharma may reconsider its expanded access position in the future as development programs mature, additional safety and efficacy data become available, and manufacturing capacity and operational resources expand. Any future changes to this Expanded Access Policy will be reflected in updates posted to our website, consistent with requirements of the 21st Century Cures Act.
For more information from the FDA about expanded access in the United States, click here. Physicians, patients, and caregivers can find additional guidance on expanded access and related topics at The Reagan-Udall Foundation’s Expanded Access Navigator.