4 new approvals for primary care exciting docs at ACP-IM
Industry Buzz
This is the first time in my 15-year history of giving this new drugs talk that I’ve given all four drugs a thumbs up, with a potential to change practice.
—Gerald W. Smetana, MD, via ACP-IM presentation
Several recently approved medications highlighted at this month’s American College of Physicians’ Internal Medicine Meeting 2026 are starting to get real attention for how they might influence frontline care.[]
These therapies focus on conditions primary care clinicians manage every day, bringing new mechanisms and additional options, while also introducing cost questions that will likely affect how often they’re used.
During his presentation, Gerald W. Smetana, MD, a professor emeritus of medicine at Harvard Medical School and Beth Israel Deaconess Medical Center in Boston, gave his take on how the drugs could be game-changing for management of conditions commonly seen in primary care.
“This is the first time in my 15-year history of giving this new drugs talk that I’ve given all four drugs a thumbs up, with a potential to change practice,” he said.[]
Motion sickness and improved tolerability
In December 2025, the FDA approved tradipitant, an oral neurokinin-1 receptor agonist, for the prevention of motion-induced vomiting. It's the first medication approved to treat motion sickness in over 40 years.[]
It works by preventing the activation of NK-1 receptors in the central nervous system, which can be the source of nausea and vomiting with motion sickness.[]
The FDA approval was based on data from two clinical trials conducted on boats, in which the drug significantly reduced vomiting in participants with a history of motion sickness compared to placebo.[]
In practice, this may open the door for patients who previously avoided treatment side effects. Where it ultimately lands will likely depend on insurance coverage and how it compares, from a cost standpoint, to well-established generics.
Acute pain: Non-opioid alternative gains traction
Suzetrigine, a drug approved in January 2025 for the management of moderate-to-severe acute pain, targets a pain-signaling pathway involving sodium channels in the peripheral nervous system before those pain signals reach the brain.[]
Related: This breakthrough pain drug provides opioid-like relief—without the risks and side effectsThe drug helps "mitigate certain risks associated with using an opioid for pain and provides patients with another treatment option," Jacqueline Corrigan-Curay, JD, MD, acting director of the FDA's Center for Drug Evaluation and Research, said of the approval.[]
This type of agent could fit naturally into multimodal pain strategies—particularly in urgent care, postprocedural settings, or musculoskeletal complaints where minimizing opioid exposure remains a priority.
Christopher Pelt, MD, called it a “game changer” for breakthrough pain.”
Uncomplicated UTI: Addressing resistance trends
Approximately one third of women in the US experience at least one UTI that requires antibiotics.[]
Not all patients respond to first-line therapies. Gepotidacin, a new drug approved by the FDA to treat uncomplicated UTI in March 2025, works by blocking the activity of two bacterial topoisomerases.[]
As resistance patterns continue to shift, having another effective oral option could make outpatient management more straightforward in select cases.
Gepotidacin was most recently approved for the treatment of uncomplicated urogenital gonorrhea.[]
Krutika Kuppalli, MD, discussed the importance of strong stewardship of the drug in a post on X:
Related: 1 Rx, rising syphilis rates, and a growing patient riskChronic spontaneous urticaria: Biologic option expands pathways
A biologic therapy is now available for patients with chronic spontaneous urticaria who remain symptomatic despite antihistamines.[]
Remibrutinib, a selective tyrosine kinase inhibitor, approved in September 2025, helps to inhibit the release of histamine and other proinflammatory mediators by targeting BTK.[]
"CSU is a serious disease that can cause debilitating symptoms and unpredictable flares. It's difficult to diagnose and manage," Mark Lebwohl, MD, dean for clinical therapeutics at the Icahn School of Medicine at Mount Sinai, said in a press release. "By blocking the activity of BTK, remibrutinib stops a key pathway of the immune response in CSU."[]
Its targeted mechanism reflects the continued expansion of immunologic therapies into conditions often managed in primary care. This may influence referral timing and expectations for disease control, particularly in patients with persistent symptoms impacting their quality of life.
What this means in practice
Across all of these therapies, cost is a recurring theme. These newer agents are expected to come in at higher price points than established treatments, which brings implications for prior authorizations, prescribing decisions, and patient adherence.
For clinicians, coverage variability and out-of-pocket costs will likely play a major role in determining who ultimately receives these therapies. In many cases, they may be most accessible for patients who haven’t responded to first-line options or who have specific clinical needs that justify their use.