|Courtesy of BioDelivery Sciences|
Health and Human Services Secretary Sylvia Burwell announced that her department will change regulations that restrict the number of patients who can be prescribed buprenorphine, to the delight of suppliers like BioDelivery Sciences ($BDSI), and hopefully to the benefit of the growing number of patients addicted to heroin and opioid-based prescription drugs.
"Updating the current regulation around buprenorphine is an important step to increasing access to evidence-based treatment--helping more people get the treatment necessary for their recovery," said Burwell at a meeting in Washington on opioid abuse, according a government release.
"Under current regulations, physicians that are certified to prescribe buprenorphine for MAT are allowed to prescribe up to 30 patients initially and then after 1 year can request authorization to prescribe up to a maximum of 100 patients. This cap on prescribing limits the ability of some physicians to prescribe to patients with opioid use disorder. The HHS revision to the regulation will be developed to provide a balance between expanding the supply of this important treatment, encouraging use of evidence-based MAT, and minimizing the risk of drug diversion," the release explains.
BDSI vice president of marketing and corporate development Al Medwar was supportive of the planned reforms, saying that currently, "there isn't enough treatment capacity out there to treat these (addicted) patients."
He said the move sidesteps congressional legislation that was considered but never passed, and said the company is awaiting additional details like the timing of the reform, as well the size of the new cap.
BDSI sells transmucosally delivered Bunavail, which contains buprenorphine and naloxone to reduce the drug's abuse potential. It competes with Reckitt Benckiser's sublingual Suboxone film.
Medwar said that Bunavail is easier for patients to use because it is delivered via the inner cheek (not underneath the tongue like Suboxone), meaning patients can talk and swallow during the ten-minute period during which the drug dissolves and is absorbed into the patient's body. He also said the drug's formulation is more efficient, saying it delivers twice as much as buprenorphine, meaning you can get the same effect with half the dose.
Secretary Burwell also announced a grant of about $1.8 million to assist rural communities purchase pure naloxone for emergency response to cases of overdose.
Medwar said BDSI does not sell pure naloxone but believes the additional step will also help fight addiction. The problem has been complicated by a recent surge in heroin use as drug users seek a new source of opioids in response to the government crackdown on prescription drug abuse.
- read the government's release
- here's BDSI's release