(Reuters) - The first-ever implant to fight addiction to opioids, a class of drugs that includes prescription painkillers and heroin, was approved by the U.S. Food and Drug Administration on Thursday.
The matchstick-sized implant, developed by Titan Pharmaceuticals Inc and privately owned Braeburn Pharmaceuticals, is by design less susceptible to abuse or the illicit resale that plagues existing oral therapies.
Fewer than half of the estimated 2.2 million Americans who need treatment for opioid abuse are receiving help, according to the U.S. Centers for Human and Health Services (HHS).
Currently, two drugs are predominantly used to treat opioid addiction — methadone, which is dispensed only in government-endorsed clinics, and the less-addictive buprenorphine, which exists as a pill or strip of film. While effective, a pill or film may be lost, forgotten or stolen.
Evidence suggests that the use of these medicines as part of the overall treatment program are more effective than short-term detoxification programs aimed at abstinence, the FDA said on Thursday.
The implant, Probuphine, administers buprenorphine for up to six months after users have been stabilized on the oral form of the drug, and is used along with behavioral therapy and recovery support.
“I intend to make this the most successful implant that’s ever been marketed ... and I think it’s absolutely possible given the unmet need,” Braeburn Chief Executive Behshad Sheldon said in an interview ahead of the FDA decision.
However, some doctors are concerned that the implant may incentivise patients to rely solely on medication, and ignore the lifestyle changes they need to make.
Braeburn estimated the U.S. market for opioid addiction treatments at about $2 billion, excluding methadone and Vivitrol, Alkermes Plc’s treatment for the prevention of relapse after opioid detoxification.
CEO Sheldon declined to specify a price for the implant on Thursday, but said it would be substantially cheaper than Vivitrol.
“We are hoping that our first patient will have received the implant by the first day of summer or June 21,” she added.
The market for long-acting therapies such as Probuphine could be even larger if attempts to raise the limit on the number of opioid addicts a doctor can treat are successful.
Under the current law, a doctor can treat only 30 opioid addicts within a year of obtaining a waiver, rising to a maximum 100 after procurement of a second waiver.
The Congress and the HHS are working toward increasing this limit.
Of particular interest is a proposal that exempts from the patient limit any treatment directly administered by a physician, such as an implant or injection.
Probuphine’s path to approval has not been smooth. In 2013, the FDA rejected the implant, saying it needed additional data.
After the submission of new trial data, FDA staff in January raised reservations about possible complications from the insertion and removal of the implant. Data also showed that some users continued to need oral buprenorphine.
Despite these concerns, an independent panel of experts to the FDA voted largely in favor of the treatment.
Thursday's approval comes with a black box warning, the most severe issued by the FDA, highlighting the risk of implant migration, protrusion, expulsion and nerve damage resulting from the procedure. (1.usa.gov/1RuiaRi)
Braeburn, in collaboration with Sweden’s Camurus AB, also has a long-acting injectable buprenorphine formulation in late-stage development.
Britain’s Indivior Plc is also evaluating a similar injectable in a late-stage study.
Reporting by Natalie Grover in Bengaluru; Editing by Sriraj Kalluvila