Big Pharma realizes Probuphine has the potential of cutting into their profits.
All the articles on price you noticed the past week or so were probably perfectly orchestrated by some faction.
I'm lad however that Braeburn had an answer for that,by stating they will be working with insurers,etc., with respect to rebates and the like,in order to make the drug more affordable to the public at large.
To think, 25% of those with opioid abuse problems have the potential to be treated in the U.S alone.....
This has potential worldwide implications, as the news has already circulated in many different languages,in many countries.
HIGH POINT, N.C. -- A new medication that could help people fight opioid addiction could be approved by the FDA next week.
Probuphine, developed by Titan Pharmaceuticals and Braeburn Pharmaceuticals, comes in the form of a small rod which is implanted into a patient’s arm.
“This is four little rods about two and a half centimeters long each. And they actually sit in a little fan-shaped pattern. They go right in the inside aspect of your arm,” Dr. Michael Frost told WGHP’s sister station WTIC.
Dr. Frost helped test Probuphine on patients over the last two years. “The most recent studies we've done showed it was extremely effective.”
The medication, Buprenorphine, is released constantly over six months. Buprenorphine has been on the market for a decade and is already used in pill form.
“With the turbulence that often accompanies active addiction, and mostly homelessness- maintaining that prescription, remembering to take it, remembering where it is, that's a huge issue,” explained Ralph Rodland.
Rodland is the executive director of Caring Services in High Point. They offer treatment and housing options for people choosing recovery.
He says if medication is part of a recovering patient’s treatment program, there is definitely an appeal to be able to implant it.
“I'm thrilled to see that they've come up with something that has a longer duration of delivery of the mediation, so it's very promising. I'm encouraged they're moving forward with approval,” said Rodland.
An FDA Advisory committee voted to approve Probuphine. A final approval decision from the FDA is expected next week.
FOX8 also spoke to Thom Elmore, the executive director at the Addiction Recovery Care Association, Inc. (ARCA) in Winston-Salem.
Elmore agreed, “One of the biggest pluses you have here is a way of being assured patients are getting the recommended dosage 24/7. The chances of it being misused or diverted to someone who shouldn’t have it are eliminated.”
Within the next week, the FDA is expected to decide whether to allow the U.S. sale of a long-acting, implantable version of an anti-addiction drug that could be used to treat opioid addiction.
Probuphine is a series of four rods about the size of matches that trained physicians place under the skin. These rods, left in for six months, release buprenorphine, a drug clinicians use now in other forms to alleviate opioid addiction.
Proponents say this device is hard to sell on the black market and prevents more relapses. Additionally, clinicians and patients like the idea of an implant rather than remembering to take daily medication. The price might be high, but addiction specialists predict high demand for the implant anyway. An FDA panel recommended Probuphine in January, and the agency is expected to announce its decision on May 27.
Meanwhile, calls continue growing for better physician training regarding opioid prescriptions. In the June issue of Pharmacology Watch, author William Elliott, MD, FACP, notes a joint meeting of the FDA’s Drug Safety and Risk Management Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee resulted in a unanimous vote to require training for all prescribers of opioids.
They further recommended that the training encompass the risk of immediate-release as well as extended-release and long-acting opioid preparations. Some panelists argue the training should focus on pain management and relate to recent CDC guidelines released in March. The full agency has not yet voted on the recommendations.
Been posting mainly on the other TTNP boards but now and then pop in to post.
Over three years now, since the CRL of 2013.
The timing is right for Probuphine.
Additionally 4,000 physicians signed up to train for the implant to be implanred and removed.
Not to mention, in the clinical trials, not one individual attempted to remove the rods one
Great starting point to lobby for no physician cap on the implant.
One week to go....
I'm all in....
Praying for addicts everywhere.