addicted, but in a safer, more controlled environment under a physician’s supervision, Pops says.
The Alkermes drug was cleared by the FDA for a different purpose—to prevent relapses after patients have undergone detoxification treatment. Scientifically, it doesn’t feed the addiction—it blocks receptors in the brain that control the “high” feeling people get by taking opioids like morphine, heroin, and oxycodone.
“Once the receptors have been blocked, even if you take OxyContin or heroin, you don’t get high because the receptors are blocked,” Pops says.
This is a big deal for professionals in the criminal justice system, who often measure their performance based on how to bring down the rate of repeat drug offenses. Putting patients on a drug that works like Vivitrol might give the justice system a better chance to break the cycle. “If you detox people and put them on Vivitrol, they can’t re-establish physical dependence,” Pops says. “It gives them a chance for counseling to take root, and for the patients to learn to live life in a different way.”
Like many things in biotech, this sounds great, but it’s really hard to prove in practice. A drug like Vivitrol isn’t sold like most pharmaceuticals, in which a sales rep cajoles a doctor into writing a lot of prescriptions for patients who dutifully pick up the medication at the pharmacy. Physicians who specialize in treating addictions can order a drug like Vivitrol for patients with health insurance, get reimbursed, and deliver the injection when the patient comes into the office.
Another way that could have even more impact, is commercializing the drug through the courts/criminal justice system. Certain counties and states around the U.S. that struggle with opioid addictions are thinking up all kinds of pilot studies tailored to their own needs, Pops says. Some places want to see if using Vivitrol will help reduce repeat drug offenses, save state money, improve overall health outcomes of patients, or some combination of all three.
Alkermes is getting those kind of inquiries from government agencies that aren’t that interested in a drug-company sponsored health economic study (likely fraught with inherent bias). So far, pilot projects are ongoing in six states that are interested in testing Vivitrol in their own hands, in their own communities, Pops says. If those pilot projects pan out, it’s possible some governments may start incorporating Vivitrol treatment into sentencing guidelines, essentially making it a part of probation terms that offenders much comply with, Pops says.
There are a bewildering number of government agencies, courts, etc. that might be interested in these kind of trial runs—which makes for complex logistics for a mid-sized company like Alkermes. Only about 60 people on a specialty sales force at the company are actively pitching the product, and a handful of people are serving as liaisons to government agencies, Pops says.
The company is being very cautious not to drum up optimistic forecasts about the product, mindful of how it created a bunch of Vivitrol cynics once before. Some analysts have actually start accusing Alkermes of being a little too cautious in managing expectations about this drug’s true potential in opioid-based addictions, Pops says.
There are always plenty of risks in commercializing a new drug. The list price is $1,100 per monthly shot, and most doctors believe patients should be on the drug for at least six months. So it’s not a bargain-basement type product, although bulk purchase discounts are available, Alkermes says. Like all drugs, it has side effects—nausea, fatigue, headache, dizziness, vomiting, decreased appetite, painful joints, and muscle cramps were listed in the FDA’s October announcement.
Alkermes, having been burned before on bullish sales forecasts in treating alcohol addition, is playing it cautious this time. Anybody with experience in the criminal justice system can talk about how hard it is for people to beat drug addiction. But Alkermes, through this product with a new kind of approach, is hoping that it can give criminal justice professionals a chance with a new tool against drug addiction. And if people are really motivated to kick their drug habit, the Alkermes treatment could give them a second chance.
“It’s a bridge to being drug-free,” Pops says. “A lot of people will take it, and stop, and want to take drugs again because they are drug addicts. But six months on this treatment gives you a chance to re-learn how to live your life.”
