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This article discusses the baseline characteristics of patients with asthma who are initiating treatment with the medication dupilumab in a real-world setting. The study is part of the Registry of Asthma Patients Initiating DUPIXENT (RAPID), which aims to collect information on the use and effectiveness of dupilumab for asthma in a clinical setting. The analysis found that 25% of the patients had used oral corticosteroids (OCS) in the three months prior to enrollment or were currently using them. Patients with and without a history of OCS use had similarly impaired lung function, indicating a high treatment need. The findings suggest that many patients in the real-world asthma population require additional therapy to reduce OCS use. [Extracted from the article]

Two formulations of azelastine nasal spray, the original (Astelin®; Meda Pharmaceuticals, Inc., Somerset, NJ) and a reformulated nasal spray (Astepro®; Meda Pharmaceuticals, Inc.), are currently indicated for treatment of seasonal allergic rhinitis. This randomized, double‐blind study, conducted among professionally trained expert panelists in Sensory Descriptive Analysis, compared the original azelastine in a saline vehicle with the reformulated nasal spray in a sorbitol‐based vehicle, focusing on bitterness of the two formulations. A total of 12 panelists were randomized to both doses (one or two sprays/nostril twice daily) of each azelastine formulation. The primary endpoint was the direct comparison of the bitterness of reformulated azelastine to original azelastine on a 15‐point scale. At a dose of two sprays/nostril, there was a statistically significant 71% reduction in bitterness with reformulated azelastine versus original azelastine (P < 0.05). In addition, nasal discomfort was less frequent with reformulated azelastine versus original azelastine. PRACTICAL APPLICATIONS: The development of a new azelastine nasal spray formulation with less bitterness began with studies that used an electronic sensing device (Alpha M.O.S. America, Hillsborough, NJ) to evaluate the degree of bitterness of several investigational formulations. These studies tested a number of different combinations of vehicles and taste‐masking agents to produce a formulation with the stability and isotonicity of the original azelastine formulation, with a reduction in bitter taste. The electronic sensing device identified candidate formulations for testing in humans. The formulations with the potential for improved tolerability were administered orally and then intranasally. Historically, the pharmaceutical industry has relied on taste analysis via in vitro methods, such as the electronic sensor, as well as human taste panels to evaluate liquid samples. Based on our current study, these methodologies appear appropriate for intranasal preparations as well. [ABSTRACT FROM AUTHOR]

Background: Carisoprodol, a centrally active skeletal muscle relaxant, is widely used for the treatment of acute, painful musculoskeletal disorders. When administered at a dose of 350 mg four times daily, carisoprodol demonstrated significant clinical benefit in its early clinical development trials; however, some unfavorable side effects, such as drowsiness and dizziness, were reported. Recently, research was conducted to determine if a lower dose of carisoprodol would retain efficacy but improve tolerability compared to the higher 350-mg dose., Objective: The purpose of this multicenter study was to compare the efficacy and safety of carisoprodol 250-mg tablets four times daily to 350-mg tablets four times daily and to placebo in patients with acute, painful musculoskeletal spasm of the lower back., Research Design and Methods: In this 1-week double-blind, placebo-controlled, parallel-group multicenter trial, patients 18 to 65 years of age with moderate to severe back spasm were randomly assigned to treatment with carisoprodol 250-mg tablets (n = 264), 350-mg tablets (n = 273), or matching placebo tablets (n = 269) three times daily and at bedtime., Main Outcome Measures: The coprimary efficacy variables were patient-rated relief from starting backache and patient-rated global impression of change assessed on treatment day 3., Results: The carisoprodol 250-mg regimen was significantly more effective than placebo as assessed by both patient-rated relief from starting backache (p = 0.0001) and patient-rated global impression of change (p = 0.0046). There were no significant differences between the 250-mg and 350-mg dosages for the coprimary efficacy endpoints, and patients improved with or without sedation. Fewer than 1% of patients in the carisoprodol 250-mg group discontinued prematurely because of treatment-emergent adverse events, and no patient discontinued because of drowsiness., Conclusions: When administered three times daily and at bedtime, carisoprodol 250 mg was as effective as 350 mg three times daily and at bedtime with a lower incidence of adverse events and fewer discontinuations of therapy due to adverse events. Patients improved whether or not they reported sedation as an adverse event.