PF614, an “around-the-clock analgesic for moderate to severe pain for an extended period of time” from Ensysce Biosciences, Inc., has been granted ‘Fast Track’ designation by the U.S. Food and Drug Administration (FDA). PF614 is a two-step extended-release oxycodone prodrug that has been designed with abuse-deterrent properties and is limited to oral administration.
In a statement made earlier, Ensysce Biosciences CEO Dr. Lynn Kirkpatrick had stated their prodrug approach to be different from other opioid abuse-deterrent formulations as they still contain a substantial amount of bioavailable opioids that can be extracted and abused. As per the company, PF614 is completely inactive until mobilized in the small intestine after an oral administration.
According to Dr. Kirkpatrick, a combination of BIO-MD™ prodrug abuse deterrent along with MPAR™ overdose protection products are unique in the field as they eliminate the ability to abuse opioids by the non-oral route, a growing problem in the U.S. that claims thousands of lives annually and leads to a significant burden to health care cost and the economy. In 2016, opioid overdose had claimed more than 42,000 lives across the country.
Understanding Fast Track system
A process designated to facilitate development and fasten the review of drugs to treat serious illnesses and fill an unmet medical need, FDA’s Fast Track process has the sole purpose of getting “important new drugs to the patient earlier.” A Fast Track designation by the FDA ensures early and frequent communication between the agency and the drug manufacturer throughout the development and review process. An early and frequent communication also helps to resolve the issues quickly, often leading to earlier approval and access by the patients. Furthermore, the designation also enables the drug to be eligible for accelerated approval and a priority review by the FDA after meeting the relevant criteria.
A fast track drug must show some advantages over existing drugs or therapies, including displaying superior effectiveness, improving the diagnosis of a condition where an early diagnosis results in improved outcomes, ability to anticipate a public health need and avoid serious side effects of an available therapy, among others.
Road to recovery
A semi-synthetic narcotic analgesic and a popular drug of abuse, Roxicodone brings relief from pain, reduce anxiety, and cause euphoria and extreme relaxation in its user when taken as prescribed. However, misuse of the drug can lead to addiction, overdose and even death. Given the drug’s addictive nature and painful withdrawal symptoms, treatment for Roxicodone addiction should always be sought at certified Roxicodone rehab facilities.
A leading behavioral and drug and alcohol addiction treatment provider, Sovereign Health of Florida’s rehab centers provide treatment programs that focus on both the physical and psychological effects of oxycodone withdrawal. For a comprehensive and lasting recovery, all our patients are provided with a personalized treatment plan that is tailored to his or her specific needs.
Oxycodone detox depends on the amount, duration and frequency of the drug abused and may involve a holistic combination of medications along with behavioral therapies or counseling sessions. To know more about the treatment programs offered at our facilities, you can call our 24/7 helpline number or chat with a representative.
Sovereign Health Group is a leading addiction, dual diagnosis and mental health treatment provider. Call our admissions team 24 hours a day, 7 days a week to get the help you deserve.