The ongoing opioid crisis in the U.S. is harrowing – 91 Americans die every day from an opioid overdose, according to the Centers for Disease Control & Prevention. Companies are searching for innovative ways to deliver opioid maintenance treatment to patients that are hoping to get clean.
Buprenorphine is a compound used for medication-assisted treatment, traditionally administered as a tablet or a patch. When Titan Pharmaceuticals (NSDQ:TTNP) began early testing of its buprenorphine implant, patients were eager to get their hands on the product.
“More than 80% of the patients who completed the first 6 months wanted to enroll in the second 6 months,” CEO Sunil Bhonsle told Drug Delivery Business News.
Titan’s long-term, continuous drug delivery platform, ProNeura, was developed to address chronic diseases, including addiction. Probuphine, the company’s 6-month buprenorphine implant for the maintenance treatment of opioid addiction, is the 1st marketed product to provide maintenance treatment continuously for 6 months following a single administration procedure.
The company licensed a patent for the technology from Bob Langer at the Massachusetts Institute of Technology in the 1990s, Bhonsle told us. Titan wanted to create something that stood out from a traditional implant, which often used a reservoir of drug inside a substrate.
“We felt anything with a reservoir would always be prone to the potential of drug dumping,” he explained, referring to when environmental factors cause an implant to prematurely release its drug.
Titan’s subdermal ProNeura implant is a match-sized rod made from a mixture of ethylene-vinyl acetate (EVA) and a drug. The product is a solid matrix that is placed in the inner part of the upper arm in an office procedure and is later removed at the end of the treatment period.
Bhonsle explained that the product boasts 100% bioavailability – as the patient’s body fluids slowly dissolve the drug, it is absorbed into the surrounding tissue and ultimately ends up in the bloodstream. The implant also delivers a steady, continuous dose of the drug over the treatment period.
The company filed an Investigational New Drug Application with the FDA and began development in 2005. Bhonsle said they thought their work was done in 2012 when they filed a New Drug Application with the FDA, but the federal watchdog asked for more clinical work despite a positive recommendation from the advisory committee.
After the company completed research using the implant in patients who had previously used an opioid maintenance therapy, Titan won FDA approval in May last year.
Although Titan’s flagship product is its Probuphine implant, it is also working on implants to treat chronic conditions such as Parkinson’s disease and hypothyroidism. Bhonsle told us that the team expects to hear from the FDA in the next couple of months regarding an Investigational New Drug Application for its Parkinson’s implant.
Bhonsle pointed out that in a patient’s fight against addiction, compliance represents a crucial part of recovery. A patient is at risk of relapsing every time they miss a dose of their treatment.
“If the patient is not compliant, they relapse very quickly and the relapse rate in patients who get off treatment tend to be in the 80% level,” he said. “One major benefit of our delivery is obviously the doctor knows that the patient is getting the medication. Compliance is not an issue,” he said.
Beyond compliance, Bhonsle said the psychological effect of an implant instead of a daily pill or a patch is powerful.
“It’s no longer a reminder of their addiction and it makes it easier for them to be engaged,” he said.
