As the American public grapples with an ongoing opioid crisis, pain management companies are looking for ways to innovate their products in an attempt to avoid potential abuse.
For years, BioDelivery Sciences International (NSDQ:BDSI) has developed mucoadhesive buccal films loaded with painkillers for pain management and addiction therapy. Now it is developing a buprenorphine depot injection that would maintain a particular drug concentration to treat opioid dependence or chronic pain for 30 days.
“One of the big problems with pain meds, as well as with drugs to treat opioid addiction, is compliance and also diversion – compliance meaning people just forget to take it or don’t take it properly or they don’t take it at all. They’re diverting it. They’re selling it. They’re giving it to somebody else,” CEO Mark Sirgo told Drug Delivery Business News. “By giving an injection, it’s not recoverable, so you don’t have to worry about compliance or diversion. There’s an unmet need in the marketplace that we’re trying to fulfill.”
Sirgo said the company hopes to bring the single-injection technology into its 1st-in-man study in the 3rd quarter of 2017.
BioDelivery Sciences’ technology platform consists of a bilayer film the size of a fingertip. The Belbuca buprenorphine buccal film is indicated for chronic pain and the Bunavail product was designed for patients suffering from opioid dependence. The company also developed Onsolis, a fentanyl buccal film for patients with breakthrough cancer pain.
The film quickly adheres to the inside of a patient’s cheek, according to Sirgo. The vacuum layer of the film keeps the drug from migrating down the oral cavity, which is crucial since opioids are not well absorbed in the gastrointestinal tract.
“Some of it does go down the GI tract, but the idea behind it is that you transport the drug quickly across that buccal mucosa with a limited amount ending up within the oral cavity and swallowed,” Sirgo said.
The film dissolves over the course of 15-20 minutes. Sirgo said BioDelivery’s technology stands out from products that are placed under the tongue because the mucoadhesive buccal films are more convenient for the patient.
“When you put something under the tongue, these products are not mucoadhesive. They don’t stick. Oftentimes, you’re instructed to not talk or swallow for 10 or 15 minutes to allow the drug to be absorbed, so that’s the big difference, and that’s why we chose to move to the buccal mucosa where we could create something that was convenient and easy for patients to use,” he said. “Once it’s in place, within a few seconds, you just go about your normal daily routine, talk, swallow, whatever. No one even knows you have it in your mouth. Typically, you can’t do that with these other products.”
Some critics have blamed industry players for the harrowing opioid addiction crisis that claims 91 lives in the U.S. everyday, according to the Centers for Disease Control & Prevention. And Sirgo said there are certainly “bad actors” in pharma that have contributed to the public health epidemic.
“There are companies out there that have recklessly allowed physicians to inappropriately use their products because they detail them in, what we call, off-label ways,” he said. Detailing is a technique used by pharmaceutical sales representatives in which they visit doctors to explain the benefits and side effects of a particular product.
He pointed to BioDelivery Science’s Onsolis fentanyl product as an example of something that could be potentially dangerous if a doctor were to prescribe it to someone other than the product’s target population.
“It’s used, or indicated, for the treatment of breakthrough cancer pain so, if you’re not a cancer patient with breakthrough pain, you should not be using this product, and nobody should be detailing a doctor who doesn’t have cancer patients in their practice, nobody should be detailing a doctor that would use it for some other purpose,” Sirgo said.
But he also said that more work should be done to educate physicians about the potential dangers of opioids and help them cultivate healthy prescribing habits, because opioids aren’t going anywhere – too many patients rely on them.
“Opioids are extremely effective drugs to treat pain of all kind, both acutely and chronically. They’re not going away. There’s nothing available to replace them,” he said. “We’ve got 110 million Americans that have suffered from chronic pain. You just can’t stop treating them, so it’s really taking a step back and making sure that people are being properly educated around it instead of trying to yank them off the market.”