Despite growing attention from lawmakers and doctors, the opioid crisis is not slowing up in the U.S. A new report published last week by the Centers for Disease Control and Prevention showed that emergency room visits for opioid overdoses jumped 30% in 45 states from 2016 to 2017.
The problem has morphed over the years – fentanyl, a powerful opioid that’s 30 times more potent than heroin, has grown in popularity among drug users, despite its deadly grip.
A nasal spray designed to reverse opioid overdoses called Narcan has become a life-saving tool used by police departments and communities around the country. Now, the company that created Narcan – Opiant Pharmaceuticals (NSDQ:OPNT) – is hoping that its latest drug-device combination can help people who are overdosing from fentanyl.
The active drug used in Narcan, naloxone, wasn’t first discovered by Opiant Pharmaceuticals. It was available for years as an injectable medicine, according to CEO Dr. Roger Crystal.
“It wasn’t being used to its full potential because of the way that it was delivered – in the case of naloxone, it was given by injection and that limited the number of patients that could really use it,” he told Drug Delivery Business News. “What we did as a company was look at how we could optimize that. We asked, ‘how can we take the existing molecule and really help patients on a larger scale?'”
Opiant Pharmaceuticals was launched in 2009 by Dr. David Sinclair, who died of cancer in April of 2015. Sinclair founded the company based on his research which showed that opioid antagonists, like naloxone, could be used to treat people who suffered from alcoholism.
According to Crystal, who is the lead inventor on Narcan’s patent, Sinclair noticed that people were making their own nasal spray kits from the injectable versions of naloxone.
“They were getting the cartridges of naloxone for injection, attaching them to a syringe and then attaching an atomizer on top and squirting that up someone’s nose,” Crystal explained.
“But it’s quite cumbersome for, let’s say, the mother of a teenager who’s an addict, if you find your son unresponsive on the floor – how can you start assembling a nasal spray kit at the scene and reliably resuscitate them?”
The company met with the FDA and proposed a development program for an opioid overdose reversal agent that would eventually be called Narcan. The nasal spray was approved in late 2015 and began generating commercial sales through Opiant Pharmaceuticals’ partner, Adapt Pharma, the following year.
Since its approval, Narcan has been used hundreds of thousands of times to bring people back from heroin or prescription pill overdoses. But as the opioid crisis rages on, powerful, synthetic opioids like fentanyl are stretching the limits of what Narcan can do.
“Fentanyl is easier and cheaper to make, but 30 times more potent. Heroin has a half life of a couple of hours. Fentanyl stays around for 7 to 8 hours,” Crystal said. “We are seeing that more and more naloxone is needed to reverse an opioid overdose in general because of the nature of what people are overdosing on.”
“And, if they’ve overdosed on fentanyl, the issue is that they could revert back into an overdose state [even after receiving naloxone], which is highly problematic,” he added.
Just as Opiant Pharmaceuticals did with naloxone, the company has turned to an old drug that was once available as an injection – nalmefene. It’s another opioid antagonist, but data from a Phase I trial has shown that it can last up to 7.8 hours. The company plans to pursue an accelerated approval pathway with the FDA and said it hopes to submit a new drug application by 2020.
In the meantime, fentanyl continues to claim the lives of thousands of Americans each year – the CDC estimates that fentanyl was responsible for nearly 20,000 deaths in 2016.
The widespread use of opioid overdose reversal drugs is not without criticism. Some communities have expressed frustration over the use of resources for people who often resume using heroin once they’ve been revived with Narcan, according to a CBS News report. But Crystal sees things differently.
“You have to save someone’s life if they’re going to get better,” he said.
Steve MacMillan took over as CEO of Hologic in 2013, drawing on his experience at medtech titans like Stryker and Johnson & Johnson. Since then, Hologic has grown into a $3 billion business.
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