Drugs

FDA Lifts Clinical Hold on Cara Therapeutics Pain Trial

FDA has lifted a clinical hold on a Cara Therapeutics adaptive pivotal trial of intravenous (IV) CR845 for postoperative pain. “A protocol-specified stopping rule, based on elevated serum sodium levels greater than 150 mmol/L, was met during the first phase of the study, and a review of unblinded safety data has been undertaken by both Cara and the Independent Data Monitoring Committee (IDMC) in accordance with the protocol,” the company says.

Cara says the safety review, which was approved by FDA, “confirmed that increases in serum sodium levels in CR845-treated patients beyond the normal range were dose-dependent and asymptomatic with the lowest frequency of events found in the 1 ug/kg IV CR845 group. Based on this safety review and an analysis of efficacy trends, the study will continue as a three-arm trial testing two doses of CR845 (1 ug/kg and 0.5 ug/kg) versus placebo.” The most common adverse events (greater than 5%) reported across treatment groups and placebo so far were nausea, hypernatremia, abdominal distension and procedural hypotension. Patient enrollment is to resume next month.

The CLIN3001 study is a multi-center, randomized, double-blind, placebo-controlled, parallel-group adaptive design Phase 3 trial with repeated doses of I.V. CR845 or placebo administered both prior to and following abdominal surgery in male and female patients, according to Cara. The trial is enrolling up to 600 patients undergoing either hysterectomy, prostatectomy, hemi-colectomy or ventral hernia repair at 30 clinical sites within the U.S. Three doses of IV CR845 (1.0, 2.0 and 5.0 ug/kg IV) are being compared to placebo. The primary efficacy measure is the “change in pain intensity” over the 24-hour postoperative period (AUC-24) using the patient-reported Numeric Rating Scale score collected at pre-specified time points through 24 hours.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome