Publications by authors named "S Sabarinath"
On May 22, 2023, the United States Food and Drug Administration approved the first nalmefene hydrochloride nasal spray for the emergency treatment of known or suspected opioid overdose in adults and pediatric patients 12 years of age and older. This approval of a new prescription nalmefene hydrochloride nasal spray adds to the available opioid reversal options for hospitals, communities, harm reduction groups, and emergency responders. Due to the life-threatening nature of opioid overdose, conducting randomized, well-controlled clinical efficacy trials in the target patient population is neither ethical nor feasible.
View Article and Find Full Text PDFThe important advances in scientific knowledge have led to a notable enrichment of therapeutic offers in the field of CKD-MBD, which have allowed better control of the related biochemical parameters compared to the past. However, this has not corresponded to a tangible improvement in the clinical outcomes, both bone and cardiovascular, associated with CKD-MBD, nor has there been a significant drop in the number of pills that nephropathic patients must take, to keep the parameters controlled biochemicals, with the therapeutic cost of these interventions remaining high. All these unsatisfied needs continue to stimulate research to find new solutions that can improve one or more of these objectives not yet achieved.
View Article and Find Full Text PDFSeveral challenges are associated with rare disease drug development in neurology. In this article, we summarize the US Food and Drug Administration's experience with clinical drug development for rare neurological diseases and discuss clinical pharmacology's critical contributions to drug development for rare diseases. We used publicly available information to identify and screen drug products approved for rare neurological indications between 1983 and 2019.
View Article and Find Full Text PDFArticle Synopsis
- - The study aimed to develop a sophisticated multistate model to analyze the frequency, severity, and duration of migraines using data from placebo groups in two clinical trials for migraine prevention.
- - Researchers created a unique model that combines survival and ordered categorical models to evaluate how migraines start and change over time, demonstrating the effectiveness of the model through internal and external validation.
- - Findings indicated that patients on placebo experienced fewer migraines, with the severity shifting towards milder forms, while age was found to influence the duration of migraines, showcasing the model's potential for broader clinical applications.
Article Synopsis
- Plasma concentrations of antimicrobial drugs are often used to connect drug exposure with effects, but unbound concentrations in plasma and tissues might differ; understanding unbound tissue concentrations is crucial for antimicrobial drug development.
- A clinical microdialysis study investigated the distribution of tedizolid, an antimicrobial drug, in subcutaneous adipose and skeletal muscle tissues after a single oral dose in 12 healthy adults, using probes implanted in their thighs.
- Results showed that unbound tedizolid levels in plasma were similar to those in adipose and muscle tissues, indicating effective distribution, with well-correlated free plasma levels influencing tissue concentrations, and overall the drug was well tolerated.