New pain drug gets FDA nod as safer alternative to addictive opioids

Today’s approval is an important public health milestone in acute pain management,

Jacqueline Corrigan-Curay, acting director of the FDA’s Center for Drug Evaluation and Research said in a statement

If this drug comes in, has the drug profile that it has and is in a competitive price bracket, it’s going to rapidly see uptake,

Rosenquist said

We haven’t had any really new tools come along in a long time,

said Richard Rosenquist, the chair of the Pain Management Department at Cleveland Clinic

We believe the mechanism of suzetrigine is relevant in both musculoskeletal and neuropathic pain,

says Negulescu

Patients still feel pain; they don’t go to zero pain sensation,

says Negulescu

We screened hundreds of thousands of compounds looking for the needle in the haystack that inhibited 1.8,

says Paul Negulescu, senior vice president at Vertex

We saw patients reporting huge decreases in pain,

says Dr. Jessica McCoun, an anesthesiologist who was one of the principal investigators on trials for both bunionectomy and abdominoplasty at CenExel in Atlanta, one of the trial sites

Suzetrigine lets me add another tool that doesn’t have liver toxicity, doesn’t have kidney toxicity, is very safe, and is at least additive and maybe even synergistic with acetaminophen and ibuprofen,

he says

This is the first study I have ever conducted where the side-effect profile for people on placebo was worse than the side-effect profile for people on the study drug,

he says

We are entering a new era where we may be able to more safely and specifically inhibit pain, and that will change our relationship to and how we think about pain,

he says

David Altshuler (physician)dr.

In trying to develop medicines that don't have the addictive risks of opioid medicines, a key factor is working to block pain signaling before it gets to the brain,

Vertex's Dr. David Altshuler, told The Associated Press last year

The new medication has side effect profiles that are inherently, not only different, but don’t involve the risk of substance abuse and other key side effects associated with opioids,

said Dr. Charles Argoff of the Albany Medical Center, who consulted for Vertex on the drug's development

It’s not a slam dunk on effectiveness,

said Michael Schuh of the Mayo Clinic, a pharmacist and pain medicine expert who was not involved in the research

Brian Abrahamsbiotechnology analyst

We believe the data reflect a near worst-case scenario for this key pipeline program,

biotechnology analyst Brian Abrahams said in a research note to investors,

It might limit some patients getting it. So we just have to kind of see, and it’s hard to tell until it kind of gets out on the market,

Mauer said

In our opinion, the drug did what we expected to do in terms of the amount of pain relief,

Arbuckle said

This drug, what it is doing is interrupting that path, so even though the tissue injury exists, the brain doesn’t know,

Bergese said

It’s not like eliminating all pain,

Arbuckle said

Stephen Waxmandr.

It is an important step forward, because it provides proof of concept that a [sodium-channel blocker] can reduce pain in humans,

said Waxman, who has no financial ties to the new drug

The more options we have, the better we’re able to treat each and every patient,

said Dr. Kimberley Mauer, an anesthesiologist at Oregon Health and Science University