A non-opioid pain med, a COVID-flu shot combo, and more: 7 drug launches to watch in 2025

Vertex Pharmaceuticals (VRTX)’ opioid alternative, suzetrigine, could potentially be the first new class of medicine to treat acute pain in over twenty years. The experimental pill treats moderate-to-severe acute pain by blocking a sodium channel called Na_V1.8. These channels are found in peripheral nerves outside the spinal cord and brain, meaning the medication can stop pain signals at the source from reaching the brain. The FDA is expected to finish its review of the drug by January 2025.

Next year, Gilead (GILD) aims to launch Sunlenca, its antiretroviral medication, as a long-acting pre-exposure prophylaxis (PrEP) treatment for HIV prevention. The company said in June that its twice-yearly injection worked with 100% efficacy at preventing HIV infections in a late-stage clinical trial. Sunlenca is already FDA-approved when used in combination with other antivirals for people with multi-drug resistant HIV.

Milestone Pharmaceuticals could launch a nasal spray called Cardamyst as early as March 2025, aimed at treating paroxysmal supraventricular tachycardia (PSVT). PSVT affects about two million people in the United States and is characterized by episodes of sudden, rapid heartbeats that often exceed 150 beats per minute. Cardamyst contains a short-acting calcium channel blocker designed to quickly restore a normal heart rhythm.

Moderna (MRNA) said in June that its experimental combination vaccine against COVID-19 and the flu produced a higher immune response than existing, standalone vaccines in a late-stage trial. The combo shot could become the company’s third product on the market, after the FDA in May approved Moderna’s mRNA-based respiratory syncytial virus (RSV) vaccine for people 60 and older. The drugmaker hopes to launch the shot for the fall respiratory disease season in 2025 or 2026.

Bristol Myers Squibb’s Opdivo, a leading treatment for melanoma and other cancers, was among the best-selling drugs in 2023, generating $10 billion in global sales. With its patent set to expire in 2028, the company is working to delay generic competition by developing a new formulation of Opdivo that can be administered more easily via a subcutaneous injection rather than an intravenously. This new version of Opdivo could be available as early as February 2025.

This May, Danish pharmaceutical company Novo Nordisk (NVO) announced results from a late-stage clinical trial showing Ozempic reduced the risk of major kidney complications, cardiovascular events, and death by 24% in patients with type 2 diabetes and chronic kidney disease. Based on these findings, Novo Nordisk has submitted a label extension application for Ozempic, which the FDA is currently reviewing, with a decision expected by January 2025. If approved, this would expand the use of the blockbuster diabetes drug, also known for its weight loss benefits, to include treating chronic kidney disease.

Eli Lilly said in April that its weight loss drug Zepbound was found to help alleviate sleep apnea in patients with obesity in late-stage clinical trials. The company said it is seeking approval from the FDA to expand the use of the drug to include treating sleep apnea. If approved by the FDA, the company plans to launch Zepbound for obstructive sleep apnea as early as the beginning of 2025.