The Rx Recap: March 9-15

Welcome to this week’s roundup of the most insightful and impactful articles from the sister publications of Dermatology Times, all under One MJH Life Sciences. Our network brings together expert perspectives, clinical advancements, and industry updates to keep clinicians informed and ahead of the curve. From cutting-edge treatments to practice management strategies, here’s a look at the top stories shaping the field of medicine.

FDA Submission Planned for Nonopioid Cebranopadol Following Positive Phase 3 Results: Tris Pharma Update

Patient Care brought us a phase 3 ALLEVIATE-2 trial reinforces cebranopadol’s potential as a novel dual-NMR agonist for acute pain management, demonstrating superior analgesic effects to oxycodone with a lower risk of misuse and dependence. Alongside the previously reported ALLEVIATE-1 trial, these findings complete the phase 3 development program, supporting Tris Pharma’s plan to submit a New Drug Application to the FDA in 2025. With a strong safety profile and promising efficacy across multiple pain conditions, including chronic pain and opioid use disorder, cebranopadol could representa breakthrough in pain treatment, offering opioid-level relief with reduced adverse effects.

Bipartisan Bill Aims to Combat PBMs’ Medicaid Spread-Pricing

This week, Drug Topics covered a bipartisan group of US Senators has introduced the Protecting Pharmacies in Medicaid Act, aiming to curb pharmacy benefit managers' (PBMs) controversial spread-pricing practices. This tactic, which allows PBMs to charge Medicaid more than they reimburse pharmacies, has been criticized for driving independent pharmacies out of business and inflating patient costs. If passed, the bill would enforce pricing transparency, require PBMs to pay pharmacies fairly, and is projected to save Medicaid $2 billion over a decade. With growing bipartisan support for PBM reform, lawmakers hope this legislation will help sustain local pharmacies and lower drug costs for patients.

Narrative Review Links Allergies and Impaired Sleep in Children

A recent narrative review outlined by HCPLive underscores a significant connection between allergies and sleep disturbances in children, with conditions like allergic rhinitis, asthma, and atopic dermatitis contributing to sleep fragmentation, insomnia, and obstructive sleep apnea (OSA). Conducted primarily in Saudi Arabia, where allergic diseases are prevalent, the review highlights how nasal congestion, wheezing, and itching disrupt sleep patterns, leading to cognitive and behavioral consequences. The findings suggest that managing allergy symptoms—through pharmacological treatments, immunotherapy, and lifestyle adjustments—can improve sleep quality. Researchers emphasize the need for further studies to better understand these interactions and enhance treatment strategies for affected children.

Dual Trial Strategy: Company-Sponsored and Investigator-Initiated

Artiva Biotherapeutics is advancing trials for autoimmune diseases, including lupus, rheumatoid arthritis, pemphigus vulgaris, and vasculitis, with a unique dual approach that Pharmaceutical Executive brought to readers this week. The company’s investigator-initiated trial is being conducted in a community setting, distinguishing its AlloNK therapy from autologous CAR-T treatments, which require specialized centers. By demonstrating the feasibility of outpatient administration, Artiva aims to make its therapy more accessible to a broader patient population. CEO Fred Aslan, MD, highlights the strategic advantages of combining company-sponsored and investigator-initiated trials to generate robust data and expand treatment options beyond tertiary care centers.

FDA accepts new drug application for low-dose atropine from Sydnexis

The FDA has accepted Sydnexis’s New Drug Application for SYD-101, a low-dose atropine eye drop for managing pediatric myopia, according to Ophthalmology Times, setting a target action date of October 23, 2025. If approved, SYD-101 would be the first pharmaceutical treatment for myopia progression in the US. The NDA is based on the STAR study, a phase 3 trial enrolling 852 patients, making it the largest study of its kind. With myopia rates rising globally, the approval of SYD-101 would provide eye care providers with a new, much-needed treatment option to slow progression and reduce associated vision risks.

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