WEST CONSHOHOCKEN, PA — PRM Pharma, LLC has announced the availability of HEMICLOR® (12.5 mg chlorthalidone tablets), the first FDA-approved low-dose formulation of chlorthalidone for the treatment of hypertension in adults. The product is now available in pharmacies across the United States, with third-party discount programs in place to support patient access.
Chlorthalidone, a thiazide-like diuretic, has been widely used to manage hypertension for decades, backed by strong evidence of its cardiovascular benefits. Until now, U.S. clinicians lacked a low-dose option, despite 12.5 mg being the starting dose utilized in landmark hypertension studies such as ALLHAT and SHEP. The introduction of HEMICLOR addresses this gap, aligning clinical practice with guideline-recommended dosing strategies.
“The evidence for the benefit of low-dose chlorthalidone spans over 30 years, but unfortunately we’ve lacked a commercially available product that enabled widespread use of the drug effectively in practice,” said Michael Ernst, PharmD, Clinical Professor at the University of Iowa. “The availability of a low dose formulation aligns with our contemporary understanding of how to optimize the benefit-risk when using the drug, and I’m excited for this new chapter in chlorthalidone’s storied history.”
The 2017 ACC/AHA hypertension guidelines recommend chlorthalidone as the preferred diuretic due to its long half-life and robust data supporting positive cardiovascular outcomes. Previously, only 25 mg and 50 mg doses were available, which made achieving guideline-consistent, lower dose prescribing challenging, potentially increasing the risk of dose-related side effects.
“Chlorthalidone has played a key role in hypertension treatment strategies for decades,” commented William B. White, MD, Professor Emeritus at the University of Connecticut School of Medicine. “Having access to a 12.5 mg dose in the U.S. may offer clinicians additional flexibility when initiating therapy and aligns with current treatment recommendations for many adult patients with stage 1 or stage 2 hypertension.”
The approval and availability of HEMICLOR represent an important advancement in hypertension management, offering clinicians a tailored option to initiate individualized therapies, especially in elderly patients who are more vulnerable to side effects from higher doses.
Joseph T. McDevitt, President and CEO of PRM Pharma, emphasized the company’s commitment to meeting clinical needs. “We are proud to introduce HEMICLOR as a new treatment option for adults with hypertension. Our mission is to address unmet clinical needs by developing low-dose pharmaceutical products that support evidence-based care,” McDevitt stated.
With HEMICLOR now accessible at pharmacies nationwide, its introduction is expected to enhance healthcare providers’ ability to deliver effective, guideline-compliant hypertension treatments while minimizing patient risks associated with higher dosages.
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