Titan Pharmaceuticals (NASDAQ:TTNP) launched a fully-virtual Probuphine implant Risk Evaluation and Mitigation Strategy (REMS) training and certification program for qualified health care providers (HCPs) who treat patients with opioid use disorder (OUD).
The program has been approved by the FDA for use during the COVID-19 pandemic and is now available to qualified HCPs at treatment centers across the U.S.
“We are grateful for the FDA’s expeditious review and approval of our fully-virtual REMS training program, which enables us to continue to certify HCPs to prescribe and administer Probuphine during this critical time when rates of opioid-related morbidity and mortality are significantly increasing,” Dr. Kate Beebe DeVarney, Titan’s EVP and CSO, said in a statement.
“We believe that the ability to continue certifying HCPs amidst the pandemic will facilitate access to our six-month maintenance treatment option for eligible patients with OUD who are now at increased risk for infection, relapse, and overdose due to the COVID-19 health crisis,” she added.
Dr. Christopher Ray, a Phoenix, Arizona-based HCP who received the training earlier this month, commented, “Titan’s virtual, REMS training is so well-planned, organized and thorough in every detail that I feel comfortable prescribing Probuphine treatment to eligible OUD patients receiving buprenorphine maintenance therapy, particularly given the COVID-19 pandemic-related restrictions that limit the frequency of face-to-face interaction with patients. I would recommend this virtual Probuphine REMS training to any qualified HCP providing long-term buprenorphine maintenance treatment for OUD.”
Probuphine is the only subdermal implant designed to deliver buprenorphine continuously for six months following a single treatment in patients clinically stabilized on no more than 8 mg of sublingual buprenorphine in combination with counseling and psychosocial support. Probuphine must be inserted and removed by a healthcare professional who has successfully completed a training program.
