New implant set to join fight against U.S. painkiller epidemic
29/04/2016 14:59
By Natalie Grover
April 29 (Reuters) - Two companies are on the cusp of taking
a new treatment for opioid addiction to the U.S. market at a
time when lawmakers are seeking ways to arrest an epidemic of
heroin and painkiller abuse that kills 78 Americans every day.
Titan Pharmaceuticals Inc TTNP.O and privately owned
Braeburn Pharmaceuticals have together developed a
matchstick-sized implant that analysts expect will be approved
next month, despite mixed reviews.
Implanted into the arm, the treatment is designed to be less
vulnerable to abuse or illicit resale than the oral drugs that
are currently used to treat opioid addiction.
The market for the implant could also be much bigger than
first envisaged should a bill gaining bipartisan support on
Capitol Hill become law. The bill aims to raise limits on the
number of addicts that an individual doctor can treat.
Drug overdoses have overtaken motor vehicle crashes and
firearms as the leading cause of injury-related deaths in the
United States, the U.S. Drug Enforcement Administration says.
Of the estimated 2.2 million Americans who need treatment
for abuse of heroin or prescription painkillers, fewer than half
are receiving help, according to the U.S. Centers for Human and
Health Services (HHS). urn:newsml:reuters.com:*:nL2N15H1UG
This has become an issue in the U.S. presidential campaign,
and experts say there is a strong appetite for updated
legislation. President Barack Obama is already pushing for $1.1
billion in new funding to expand treatment. urn:newsml:reuters.com:*:nL2N15H1UG
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.
The implant, known as Probuphine, offers an alternative by
administering buprenorphine for up to six months after users
have first been stabilized on the oral form of the drug.
It was developed by Braeburn, owned by New York City-based
venture capital firm Apple Tree Partners, and Titan, a San
Francisco-based developer of proprietary therapeutics.
"This epidemic isn't going away," Braeburn Chief Executive
Behshad Sheldon said in an interview. "No matter who is in the
White House or Congress, there is going to be a continual push
to come up with new and innovative solutions."
Staff at the U.S. Food and Drug Administration have raised
reservations about possible complications from the insertion and
removal of the 26mm (1-inch) long implant. Trial data has also
shown that some users still need oral buprenorphine.
However, an independent panel of experts to the FDA has
voted largely in favor of the treatment. Given the size of the
epidemic, analysts say they expect FDA approval by May 27.
Other companies could also enter the market.
Indivior Plc INDV.L , spun off from British consumer goods
company Reckitt Benckiser Group Plc RB.L , has a buprenorphine
injection in a late-stage study.
Raleigh, North Carolina-based BioDelivery Sciences
International Inc BDSI.O , which already sells buprenorphine
film, is also working on an injectable.
WAITING LISTS
Despite recent guidelines to prescribe fewer opioids for
pain relief, the U.S. market is expected to grow to $18 billion
by 2021 from $11 billion in 2014, according to GBI Research.
Yet fewer than 30,000 of the country's 800,000 or so
physicians are eligible to prescribe buprenorphine for
addiction, according to the National Alliance of Advocates for
Buprenorphine Treatment.
Under current law, a doctor can treat only 30 addicts within
a year of obtaining a waiver, rising to a maximum 100 after
procurement of a second waiver.
This is done to minimize the risk of illicit redistribution,
as well to ensure an adequate level of care for each patient.
But opponents argue that it has left the healthcare system
unable to cope with the rising number of addicts.
"Even at 100, all of us that are active in the field still
have a waiting list," said Dr. Richard Soper, chief medical
officer of the Nashville-based Center for Behavioral Wellness.
A bill called The Recovery Enhancement for Addiction
Treatment (TREAT) Act aims to change this. It includes a
provision to raise the patient cap to 100 in the first year and
500 thereafter.
It would also exempt from the cap any treatment directly
administered by a physician - such as an implant or injection.
Backed by Republican Senator Rand Paul and Democratic
Senator Edward Markey, the bill won the unanimous backing of the
U.S. Senate Health, Education, Labor and Pensions Committee on
March 16. Since then, Titan's shares have risen more than 70
percent.
To be sure, the bill's passage is far from assured.
Should it falter, a plan B exists in the form of a proposal
by the Centers for Health and Human Services to raise the
patient limit to 200, which would not require congressional
approval. urn:newsml:reuters.com:*:nL2N1701QA (http://1.usa.gov/22KJI0S)
However, the cap would still begin at 30 and would rise to
200 only in stages - not enough to make a significant difference
in the eyes of drug developers.
(Reporting by Natalie Grover in Bengaluru; Editing by Robin
Paxton and Ted Kerr)
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Keywords: HEALTHCARE TITAN PHARMA/