Duloxetine Hydrochloride

TUESDAY, Jan. 7, 2025 -- Incident use of gabapentin is not associated with an increase in fall-related hospital visits compared with duloxetine use, according to a study published online Jan. 7 in the Annals of Internal Medicine . Alexander Chaitoff, M.D., M.P.H., from the University of Michigan School of Medicine in Ann Arbor, and colleagues describe the risk for fall-related outcomes in older adults with diabetic neuropathy, postherpetic neuralgia, or fibromyalgia starting gabapentin versus duloxetine treatment. The analytic cohort included 57,086 older adults initiating treatment with gabapentin (52,152 adults) or duloxetine (4,934 adults). The researchers found that the weighted cumulative incidence rates of a fall-related visit at 30, 90, and 180 days were 103.60, 90.44, and 84.44 per 1,000 person-years, respectively, for gabapentin users and 203.43, 177.73, and 158.21 per 1,000 person-years, respectively, for duloxetine users. A lower hazard of falls was seen for incident gabapentin users at six-month follow-up (hazard ratio, 0.52), but no difference was seen in the risk for experiencing severe falls. Across sensitivity and subgroup analyses, the results were similar. "Incident gabapentin use, compared with incident duloxetine use, was associated with fewer fall-related health care visits and smaller differences in absolute measures and was not associated with an increase in more severe fall-related events," the authors write. "These considerations should be incorporated into conversations with patients who are considering starting gabapentin treatment."

Strong Interest in Trial Participation Resulted in Enrollment Exceeding Target by 20 Percent and Completion Ahead of Schedule Top-line Data Expected in Q1 2025 Nov. 26, 2024 -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today announced the completion of patient enrollment in the PROGRESS (A Phase 2b, Dose-ranging, Randomized, Double-blind, PlacebO-controlled, Parallel-GRoup, MulticEnter Study with an Open-label Extension in PatientS with Diabetic Peripheral Neuropathic Pain) study evaluating LX9211, a novel, orally-delivered, selective investigational small molecule inhibitor of adaptor-associated kinase 1 (AAK1), for the treatment of diabetic peripheral neuropathic pain (DPNP). The study successfully enrolled 494 patients, approximately 20 percent more than originally targeted, marking a significant milestone in the trial and increasing study power. Top-line data from PROGRESS is expected to be announced in Q1 2025. "We are pleased to have completed enrollment for the PROGRESS study of LX9211 in DPNP, a condition for which there is significant need for new, non-opioid treatment options," said Craig Granowitz, M.D., Ph.D., Lexicon’s senior vice president and chief medical officer. "The strong interest in this study resulted in enrollment significantly exceeding the target and completion of enrollment eight weeks ahead of schedule, underscoring the urgent demand in DPNP. We are confident that the greater-than-expected enrolled patient population will lead to critical insights, inform our Phase 3 design and add to the body of evidence supporting the use of LX911 in treating neuropathic pain and we look forward to sharing top-line findings from the study early next year." PROGRESS commenced in December of 2023 with the goal of enrolling adult patients with a diagnosis of diabetes (type 1 or type 2) with moderate to severe DPNP. The study is placebo-controlled with a primary endpoint of reduction of Average Daily Pain Score (ADPS) at 8 weeks. Secondary endpoints include change from baseline in burning pain and pain interference with sleep. Study design permitted patients to maintain one stable-dose DPNP therapy (gabapentin, pregabalin or duloxetine) without being forced to withdraw from therapies that, although inadequate, may be providing benefit – aligning with how new DPNP drugs are likely to be used in practice. DPNP is a type of nerve damage caused by chronically high blood sugar and is a major disabling and devastating consequence of long-term diabetes. It can result in pain, numbness, and other symptoms in the hands, feet, legs, and arms. There are approximately 20 million patients in the U.S. who are suffering with some type of neuropathic pain, of which about 5 million have DPNP. Discovered using Lexicon’s unique approach to gene science, LX9211 is a potent, orally delivered, selective, investigational small molecule inhibitor of AAK1. Lexicon identified AAK1 in its target discovery efforts as a promising approach for the treatment of neuropathic pain. Preclinical studies of LX9211 demonstrated central nervous system penetration and reduction in pain behavior in models of neuropathic pain without affecting opiate pathways. LX9211 received Fast Track designation from the U.S. Food and Drug Administration for development in DPNP. Lexicon is a biopharmaceutical company with a mission of pioneering medicines that transform patients’ lives. Through the Genome5000™ program, Lexicon’s unique genomics target discovery platform, Lexicon scientists studied the role and function of nearly 5,000 genes and identified more than 100 protein targets with significant therapeutic potential in a range of diseases. Through the precise targeting of these proteins, Lexicon is pioneering the discovery and development of innovative medicines to treat disease safely and effectively. Lexicon has a pipeline of promising drug candidates in discovery and clinical and preclinical development in neuropathic pain, hypertrophic cardiomyopathy (HCM), obesity, metabolism and other indications. For additional information, please visit www.lexpharma.com. The content above comes from the network. if any infringement, please contact us to modify.