First sublingual medication for agitation in serious mental illness approved
The FDA approved Igalmi (dexmedetomidine) sublingual film for the acute treatment of agitation associated with schizophrenia or bipolar I or II disorder in adults. It is the first orally dissolving, self-administered sublingual treatment for this indication.
Igalmi has a demonstrated onset of action as early as 20 minutes and shows a high response rate in patients at both 120 mcg and 180 mcg doses. In clinical trials of Igalmi, the most common adverse reactions were somnolence, paresthesia or oral hypoesthesia, dizziness, dry mouth, hypotension, and orthostatic hypotension; all adverse reactions were mild to moderate in severity.
Igalmi is a product of BioXcel Therapeutics.
Ozempic 2 mg dose approved for additional glycemic control
A 2 mg dose of Ozempic (semaglutide) injection is now approved as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus (T2DM) and to reduce the risk of major cardiovascular events in adults with T2DM and known heart disease. Ozempic injection is a glucagon-like peptide-1 analogue administered once weekly. The new 2 mg dose will be supplied as 8 mg/3 mL (2.68 mg/mL) of semaglutide in a single-patient-use pen delivering four doses of 2 mg per injection. Previously, Ozempic was available as a single-patient-use pen delivering 0.25 mg, 0.5 mg, or 1 mg per injection with a maximum recommended dosage of 1 mg weekly. The new 2 mg dose is an additional option so patients can stay on the same medication even if their blood glucose needs change.
Ozempic is a product of Novo Nordisk.
CDC: STDs continued to increase in 2020, with surge in syphilis cases
The CDC announced that the rate of sexually transmitted diseases (STDs) in the US continued to increase in 2020, with a surge in cases of syphilis driving another year of increases in congenital syphilis. "Even in the face of a pandemic, 2.4 million cases of STDs were reported in the US," the agency noted. "Jurisdictions reported more than 2,100 cases of congenital syphilis, an increase of almost 15% since 2019 and a 235% increase since 2016."
Gonorrhea and primary and secondary syphilis cases increased by 10% and 7% respectively from 2019 to 2020, whereas reported cases of chlamydia declined 13%. However, because chlamydia infections are usually asymptomatic and identified through screening, the decline in chlamydia cases is likely due to decreases in STD screening and underdiagnosis during the pandemic rather than a reduction in new infections. COVID-19 significantly affected STD surveillance and prevention efforts, the CDC notes. Some racial and ethnic minority groups, gay and bisexual men, and youth continue to experience high rates of STDs.
FDA approves first COVID-19 diagnostic using breath samples
The FDA granted emergency use authorization for InspectIR COVID-19 Breathalyzer, the first COVID-19 diagnostic test to use breath samples to detect chemical compounds associated with a SARS-CoV-2 infection. The test can be performed in environments where the patient specimen is both collected and analyzed, such as healthcare providers' offices, hospitals, and mobile testing sites using an instrument approximately the size of a piece of carry-on luggage.
The test provides results in less than 3 minutes and was shown in a clinical trial to have 91.2% sensitivity and 99.3% specificity.
The InspectIR COVID-19 Breathalyzer is a product of InspectIR Systems.