Why aren't more new pain therapies being developed?

The new season of the I am BIO Podcast is here, with an episode on the dismal pain pipeline and how we can advance needed therapeutics. Plus, we’re showing our stripes on Rare Disease Day in the U.S. and Europe. (690 words, 3 minutes, 27 seconds)

Why aren’t more new pain therapies being developed?

Pain is the most common reason people go to the doctor, yet development of new pain treatments is limited, due to regulatory and investment challenges, details the new season opener of the I am BIO Podcast, released today.

Why it matters: Pain is a daily problem for 50 million in the United States, says BIO CEO Rachel King to open the show. Chronic pain is “the number one reason for disability,” adds Cindy Steinberg of the U.S. Pain Foundation.

The big problem: Though we urgently need pain therapies, since 2017 there has been a 44% reduction in the number of pain drugs in the pipeline, says David Thomas, BIO’s VP of Industry Research, who produced BIO’s new report on the pain and addiction pipeline.

The hurdles ahead: The Inflation Reduction Act (IRA) provides longer price protection for large-molecule biologics, discouraging small-molecule drugs, Thomas notes. But pain drugs are generally small molecules, as they need to get past the blood-brain barrier. The FDA also needs to identify biomarkers for expedited drug development.

New approaches: Based on decades of costly research into the sodium channel of sensory nerves, Vertex is developing an approach unlike anti-inflammatories or opioids, says Vertex SVP Paul Negulescu. South Rampart Pharma, meanwhile, is developing a drug with a mechanism similar to Tylenol’s acetaminophen, but without negative impacts on the liver and kidneys, says CEO Hernan Bazan. 

The bottom line: “We need more breakthroughs in the pain pipeline. BIO's report shows that investment in pain and addiction remains disproportionate to the gravity of the societal problem,” King concludes. We need improved regulation and “continued commitment by researchers, advocates, and drug developers like our guests.”

Listen: The new season of the I am BIO Podcast is available via Apple, Google, Spotify, or wherever you get your podcasts, with new episodes released every other Tuesday.

Rare Disease Day shines a light on need for R&D

February 28 is Rare Disease Day, an opportunity to highlight the need for R&D for orphan and rare diseases. 

By the numbers: More than 7,000 rare diseases exist, and approximately 30 new ones are identified each year. While each individual disease affects fewer than 200,000 patients in the U.S., around 25-30 million Americans live with a rare disease.

The big problem: 95% of rare diseases have no treatment.

Advocacy is key to the Rare Disease Day/Week—part of “a long-term strategy of the biotech community to build greater interest in understanding the importance of patients’ lived experiences,” adds BIO’s VP of Government Relations, Aiken Hackett.

Why it matters: "Supporting patients with rare diseases is the heart of Rare Disease Day," says Michele Oshman, BIO’s VP for External Affairs.

It’s Rare Disease Day in Europe, too. Our friends at EUCOPE explain why we need “a holistic and systemic design approach to tackling rare diseases,” especially with the revision of the EU Pharmaceutical Package coming up—read more.

Listen: EUCOPE’s new Sounds of Science podcast episode explores how we can advance equitable access to care and diagnosis for people living with a rare disease.

More News: 

Reuters: U.S. disagreement on Mexico corn decree ‘politically motivated,’ Mexico says
“The United States’ disagreement with Mexico over its plan to limit imports of genetically modified corn is ‘politically motivated,’ Mexico’s economy ministry said on Monday. … U.S. Agriculture Secretary Tom Vilsack said last week Mexico’s decision was ‘not a situation that lends itself to a compromise.’ Mexico’s economy ministry seemed to criticize the comment from Vilsack, saying that ‘as the (secretary) himself would recognize, (the disagreement) is an issue of principles.’”

President Biden’s Tuesday: Discussing health care in a speech in Virginia Beach that The Washington Post says can be considered a preview of Biden’s presidential campaign.

What’s Happening on Capitol Hill: The House Oversight Committee will hold a roundtable, “Preparing For the Future By Learning From the Past: Examining COVID Policy Decisions,” with testimony from three medical school doctors. The House Agriculture Committee plans a hearing on “Uncertainty, Inflation, Regulations: Challenges for American Agriculture.”