By Robert Brodsky (source)

For decades, Americans struggling with pain had two options to find relief: over-the-counter medication such as ibuprofen, which often provided limited reprieve, or prescription opioids, and the risk of addiction and overdose.

Now a third option is available after the U.S. Food and Drug Administration last week approved Vertex Pharmaceuticals’ Suzetrigine, sold as twice-daily Journavx, a non-addictive prescription drug for short-term pain that often follows surgery or injuries.

Long Island physicians and treatment experts said the oral medication — the first new painkiller approved by the FDA in a quarter century — could be an important asset in curbing the region’s opioid crisis, providing a pain treatment without the addictive properties of opioids such as Vicodin or OxyContin.

But the drug, experts said, has limitations. It's not prescribed for chronic pain, while the cost — at $15.50 per 50 mg pill — could be prohibitive to some.

WHAT NEWSDAY FOUND

• The FDA last week approved twice-daily Journavx for short-term acute pain, a potential non-addictive alternative to opioids such as OxyContin and Vicodin.
• The medication, the first new type of painkiller approved by the FDA in 25 years, has the potential to help curb the island's opioid crisis, treatment experts said.
• But Journavx has its limitations, experts said, as the drug is not approved yet for chronic pain and at $15.50 per pill is more expensive than most opioids.

Adam Birkenstock, director of programming at the Long Island Council on Alcoholism & Drug Dependence in Westbury, said painkillers have been among the largest drivers of the opioid crisis.

"The hope with new treatments for pain is that patients will have more and safer options for managing symptoms but those treatments have to be affordable and accessible," Birkenstock said. "If this new medication isn't as affordable, available, and effective as opiate medication, more of our friends and neighbors will fall through the cracks."

'Public health milestone'

The FDA approved Journavx on Thursday following a pair of clinical trials on 874 participants with moderate to severe acute pain following abdominoplasty — commonly known as a 'tummy tuck' — or bunion removal surgeries.

Trial participants received Journavx, a placebo, or Vicodin. Journavx provided more relief than the placebo and had roughly the same effect as Vicodin, each reducing pain levels by three points on the standard 10-point pain rating scale, regulators said. But Journavx worked faster with fewer side effects, they said.

In a statement, Dr. Jacqueline Corrigan-Curay, acting director of the FDA's Center for Drug Evaluation and Research, said approval of Journavx "is an important public health milestone in acute pain management."

The most common side effects, Vertex said, were itching, muscle spasms, increased levels of creatine phosphokinase — a protein and enzyme that helps muscles produce energy — in the blood and rash.

"We have the opportunity to change the paradigm of acute pain management and establish a new standard of care," Dr. Reshma Kewalramani, chief executive and president of Vertex, said of Journavx in a statement.

To date, Journavx is approved only for acute pain, although Vertex is conducting trials of the drug’s efficacy with individuals experiencing chronic pain.

Cutting opioid usage

The scourge of opioid addiction has claimed thousands of lives on Long Island since the late 1990s, although there have been signs of progress in recent years.

There were 463 fatal overdoses in Suffolk in 2023, a more than 11% drop from the 524 reported in 2022, according to data from the county medical examiner’s office. State figures show 210 people in Nassau died from overdoses in 2023, down 16% from 250 deaths in 2022.

"People who are vulnerable to opioid addiction, or addiction in general, if you give them a couple of opioid painkillers for a tooth extraction ... then it becomes a problem afterward," said Dr. Manassa Hany, Northwell Health's division director for substance abuse disorders. "So this is really going to make a huge difference in the opioid epidemic in that we will spare those who are vulnerable the exposure to unnecessary opioid use."

Lori Carbonaro of Selden, whose son Nick died of a heroin overdose in 2014 at the age of 22, said she's "cautiously optimistic" about the medication but wants to learn more about the drug's long-term effects.

"How long do people stay on it? Will they prescribe a higher dose?," said Carbonaro, who, since her son's death, has become an advocate for families with loved ones lost to overdoses.

" ... I'm very skeptical," she added. "But I do have hope."

Cost concerns

Dr. William Caldwell, medical director of the Stony Brook Center for Pain Management, said Journavx is promising but has its limitations.

"The benefit of Journavx is the potential that a patient's pain can be controlled without the addition of opioid pain medications which are often not well tolerated by patients with the risk of developing opioid use disorder," Caldwell said in an email. "The limitations of Journavx are how it will work in the chronic pain population."

The other limitation, experts said, is the drug's cost and whether it will be covered by insurance.

At more than $30 per day for two pills, Journavx is roughly double the average out-of-pocket cost for acetaminophen/hydrocodone, federal data shows.

But with Journavx designed for short-term pain, medical experts said patients should only be taking it for a few days anyway.

Jeffrey Reynolds, president and chief executive of the Mineola-based Family & Children’s Association, said that since the opioid crisis migrated from oxycontin and hydrocodone to fentanyl, the biggest beneficiary of Journavx might be for patients undertreated for their pain.

"Providers have become reluctant to prescribe opioids," he said, "and that’s left patients in pain, which often leads to mental health conditions like depression."

With Virginia Huie