Pharmacology News

The FDA issued a complete response letter for the new drug application for obeticholic acid for treatment of fibrosis due to nonalcoholic steatohepatitis, according to a press release from Intercept Pharmaceutical Inc.

Evenity, a monoclonal antibody that inhibits sclerostin used to treat osteoporosis, may increase patients’ risk for adverse cardiovascular events, according to research published in Science Translational Medicine.

An intranasal dry powder formulation of dihydroergotamine, called STS101, outperformed other formulations of the drug for the treatment of migraine pain, according to researchers.

In the United States, 30% to 35% of adults experience brief symptoms of insomnia and 10% of adults have a chronic insomnia disorder, according to the American Academy of Sleep Medicine.

The National Institute on Drug Abuse states that self-help groups, “so long as they do not discourage participants from taking medications, can be particularly helpful during recovery” from opioid addiction.

Ubrogepant provided pain relief to patients with migraine in a real-world setting, according to preliminary results of an ongoing study evaluating recently approved treatments.

DFN-15, a 120 mg oral celecoxib solution, was shown to be safe and effective among patients with episodic migraine in two phase 3 studies presented at the American Headache Society Annual Meeting.

Treating patients who have chronic migraine with both onabotulinumtoxinA and calcitonin gene-related peptide monoclonal antibody medications could reduce their monthly migraine days by an additional 5.6 days than if they had just received onabotulinumtoxinA alone, according to research presented at the American Headache Society Annual Meeting.

Fewer than one in five patients with migraine who have 4 headache days or more each month go through the steps needed to receive preventive treatment, according to results from the OVERCOME study presented at the American Headache Society’s Annual Meeting.

The FDA has approved dolutegravir tablets and dolutegravir tablets for oral suspension to treat HIV infection, in combination with other antiretroviral agents, among pediatric patients at least 4 weeks old and weighing 3 kg or more, according to a press release.