BioPharma, Pharma

In 2016, the opioid epidemic hit home

In February of this year, the FDA approved the Narcan nasal spray to revive patients that had overdosed on opioid drugs. But the real story of 2016 was how widely that antidote was needed. The epidemic reached all corners of America in deadly new synthetic forms, raising unprecedented awareness about the dangers of opioid use — without yet bringing the death toll down.

narcan_product_image_3

Opiant Pharmaceutical’s naloxone nasal spray designed to reverse opioid overdoses

Opioids, both legal and illegal, now kill more Americans than gun violence does. That death toll has been rising for some time. What changed this year was the public’s awareness of the issue — think Prince and fentanyl — and the resources to fight it – think 21st Century Cures Act.

Three to five years ago, opioid addiction usually meant heroin addiction, explained Roger Crystal, CEO of Opiant Pharmaceuticals, the developer of the newly-approved Narcan nasal spray that works to reverse opioid overdoses. Those heroin addicts were depicted as stereotypical junkies and society could argue it was their fault.

“You couldn’t relate to that type of person,” Crystal said in a recent phone interview. “Now, it’s a disease of soccer moms. People here can get hold of opioids very, very easily.” 

The opioid epidemic has infiltrated ever layer of society — an example of how it can strain families is captured in J.D. Vance’s 2016 bestselling memoir — The Hillbilly Elegy — and America is now awakening to the gravity of the situation.

“In the U.S., addiction is actually more of a severe disease than cancer,” Crystal declared. “Why do I say that? Firstly, more people have it and secondly, there’s actually more deaths from addiction than from cancer in any year. From a health economics perspective, it’s also more costly to treat. So whether we like it not, we are faced with this problem and we need to invest more.”

Expanded use of naloxone
As the use of opioids has skyrocketed, use of agents that fight against their effects has also risen. 

presented by

Naloxone was on the frontline of the epidemic in 2016, being delivered in various forms. The drug itself is decades-old, but in February of this year, Opiant’s Narcan nasal spray version got the FDA nod. It offers an alternative to the syringe delivery methods typically used by first-responders.

“Even if the injection was permitted to be used by a larger population, people tend not to want to inject people,” Crystal said.

That’s especially appealing to healthcare providers treating substance abusers who have a higher likelihood of having HIV or hepatitis. The drug comes with very few side effects, Crystal said, but it must be administered quickly to restart the patient’s breathing.

Having developed the antidote, Crystal is now focusing R&D efforts towards tackling the 800-pound gorilla opioid use: the actual addiction. 

roger-crystal_mg_6473

Roger Crystal, CEO of Opiant Pharmaceuticals

“The onus is on us as a company is to go upstream of the overdose,” he said. “Overdose is the ultimate complication of the addiction. So we, ideally, would prefer you didn’t overdose in the first place. We want to go upstream of overdose and try to treat the addiction itself.”

Meanwhile, the introduction of the nasal spray coincided with a push for more and more individuals and organizations to be armed with the overdose antidote. In December the Washington Post reported that some funeral homes in a badly-hit region of Canada are stocking the naloxone spray. Why? It’s because they need to protect their staff who may be exposed to the drug when handling overdosed bodies. They also want the drug on hand for funerals, when grieving friends and relatives who are also opioid-dependent are at a higher risk of overdosing.

Naloxone prices soar
As the nasal spray gets stocked in unlikely places like funeral homes, its predecessor product — the naloxone standard and auto-injection versions — have seen prices jump up. 

Virgina-based Kaléo seems to have taken its pricing cues from Mylan. In less than two years it raised the list price on its Evzio naloxone auto-injectors from $690 for a two-pack to $4,500. The cost of pre-filled syringes also doubled in 2014, to $39.60. The nasal spray is around $125 for a two-pack, more than the syringe but significantly less than the autoinjector.

To prevent price hikes as demand escalates, Adapt Pharma, the company marketing the product on behalf of Opiant, agreed to a one-year price freeze in Ohio. Qualified purchasers who buy in bulk can purchase a two-pack for $75, a 40 percent discount on the Wholesale Acquisition Cost.

Freezing costs and upping doses
Narcan is different from other opioid antidotes, not simply in price and delivery form, but in actual dosage too. And that’s in response to the scourge that fentanyl and carfentanil represent. 

The synthetic opioid fentanyl entered the public consciousness on April 21 when it claimed the life of the celebrated musician Prince. In the first half of 2016, fentanyl was detected in two-thirds of patients who died from opioid overdoses in Massachusetts.

As if fentanyl wasn’t deadly enough, carfentanil has also crept into the United States. Once considered an elephant tranquilizer, it packs a blow 100 times more powerful than fentanyl.

That has prompted some changes in the Narcan nasal spray.

“We actually use a higher dose of naloxone compared to a lot of the injectable formulations and the reason why is that we’re seeing more and more people, unfortunately, not just overdosing on heroin, but actually the longer acting opioid painkillers,” Crystal said.

In fact, medical workers told the Boston Globe in October that overdosed carfentanil patients may need six or more doses of the standard 2-milligram naloxone products to prevent immediate death.

2017 presents a grim picture on this front.

“We’re going to see a far greater proportion of overdoses arising from fentanyl, carfentanil, and compounds we don’t yet know about,” Crystal predicted.

Addiction as a disease
It’s safe to say that anti-overdose therapies are a band-aid, not a solution, with U.S. Surgeon General Vivek Murthy calling for a recognition that addiction is a disease. 

In his first ever report on addiction, Murthy stated that there were 47,055 drug overdose deaths in 2014. Of those, a record 28,647 people died from an overdose involving some type of opioid, including prescription pain relievers and heroin.

Murthy’s aim was not simply to raise awareness, however. The surgeon general called for all stakeholders to recognize that addiction is a disease that should be treated with the same care and respect given to other conditions.

“For far too long, too many in our country have viewed addiction as a moral failing. This unfortunate stigma has created an added burden of shame that has made people with substance use disorders less likely to come forward and seek help. It has also made it more challenging to marshal the necessary investments in prevention and treatment”

It’s a movement that needs to continue throughout 2017 given that only 20 percent of people that require treatment for an opioid abuse disorder are currently receiving it.

“From a societal perspective, more recognition of addiction as a disease is only going to be helpful,” Crystal said. “It’s going to help with things like reimbursement and getting the right patients into the right care.”

Addiction costs the U.S. an eye-popping$400 billion each year, according to Murthy’s report.

Ryan Lewis (left) and Macklemore accept GRAMMY Award

Ryan Lewis (left) and Macklemore accept GRAMMY Award

Rapper teams up with Obama
Aside from the Surgeon General, even rappers are shining a light on the problem.

Seattle, Washington rapper Macklemore teamed up with President Obama to discuss opioid addiction and its stigma during the President’s weekly address.

In October, the rapper released the song “Drug Dealer (Feat. Ariana Deboo),” which pointed the finger at many groups for stoking the public health crisis. The lyrics read:

My drug dealer was a doctor, doctor
Had the plug from Big Pharma, Pharma

He also called out the public’s disregard of the issue, until it started affecting white, suburban soccer moms.

Now it’s getting attention ’cause Sara, Katey and Billy
But this shit’s been going on from Seattle out to South Philly
It just moved about the city
And spread out to the ‘burbs
Now it’s everybody’s problem, got a nation on the verge

In an email forwarded by a representative, Patrice A. Harris, chair of the AMA Task Force to Reduce Opioid Abuse, told MedCity News she welcomed the media spotlight.

“Macklemore – like other artists – is raising awareness of the desperate need for increased treatment as well as the need to end the stigma associated with having a substance use disorder.”

The fight for more funding
The message seems to have been heard in the highest corridors of power. In September, President Obama declared the first-ever “Prescription Opioid and Heroin Epidemic Awareness Weekcombining the announcement with a variety of legislative moves designed to counter the epidemic. The President also urged Congress to free up $1.1 billion in new funding specifically for this area of drug abuse.

Congress eventually approved $500 million in December, as part of the bipartisan 21st Century Cures Act.

The human face of the epidemic
Amidst all the stats and the facts and the funding, stands a photo that epitomizes the societal toll of the opioid crisis.

Released on Facebook by the police department of East Liverpool, Ohio, its shows two adults overdosed in the front of an SUV with a four-year-old child in the back.

The controversial police photo of parents passed out from opioid abuse with a four-year-old child in the back.

Source: East Liverpool Police Department

Critics attacked the department for shaming the caregivers and the child, who’s face was not blurred in the original image.

Justifying their actions on the department’s facebook page, the officers said they wanted to show the world a glimpse of what they now encounter every day.

We are well aware that some may be offended by these images and for that we are truly sorry, but it is time that the non drug using public sees what we are now dealing with on a daily basis.

2016 was then the year that the opioid crisis became stamped on the mass psyche. Whether or not it has been a turning point in the war against opioid abuse, only time will tell.

Photo: Opiant Pharmaceuticals