WEST CONSHOHOCKEN, PA — The U.S. Food and Drug Administration (FDA) has approved HemiClor, a 12.5 mg chlorthalidone tablet developed by PRM Pharma, LLC, for the treatment of hypertension in adults. This groundbreaking low-dose option is set to offer clinicians more flexibility in tailoring care aligned with current medical guidelines.
Chlorthalidone, a well-regarded thiazide-like diuretic, has been a mainstay in hypertension management for decades. Its long half-life and proven cardiovascular benefits have consistently positioned it as the preferred option within major treatment protocols, including the 2017 ACC/AHA hypertension guidelines. Clinical trials such as the ALLHAT and SHEP studies, funded by the National Heart, Lung, and Blood Institute, have supported the use of 12.5 mg doses as effective in reducing cardiovascular risks.
Until now, U.S. patients had access only to higher-dose formulations of chlorthalidone (25 mg and 50 mg). The introduction of HemiClor addresses this gap, providing a lower starting dose that aligns with recommendations and offers benefits such as reduced risks of adverse metabolic effects, including hypokalemia and hyperuricemia.
“Chlorthalidone has played a key role in hypertension treatment strategies for decades,” noted Dr. William B. White, 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.”
This development is particularly valuable for elderly patients, who may face a higher susceptibility to dose-related side effects. PRM Pharma’s low-dose formulation supports individualized care, addressing unmet needs in the treatment landscape.
Joseph T. McDevitt, President and CEO of PRM Pharma, stated, “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. Lower effective doses may offer a more individualized approach to initiating therapies.”
HemiClor is slated to launch in pharmacies nationwide beginning in May 2025, marking a significant milestone in the field of hypertension management and enhancing care options for millions of patients.
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