Oral drug approved for relapsing MS
The FDA approved diroximel fumarate (Vumerity), an oral disease-modifying therapy for people with relapsing forms of multiple sclerosis (MS), including clinically isolated syndrome, relapsing-remitting MS, and active secondary progressive MS.
According to the National Multiple Sclerosis Society, diroximel fumarate is similar to dimethyl fumarate (Tecfidera) but has a distinct chemical structure that has been shown to have fewer reported gastrointestinal adverse reactions. Diroximel fumarate's approval is based largely on the results of twice-daily treatment with the drug in clinical trials, in which it was shown to significantly reduce relapses and disease activity on MRI and in one trial in which it reduced progression of disability.
Diroximel fumarate's most common adverse reactions include flushing, redness, itching, or rash, as well as nausea, vomiting, diarrhea, stomach pain, or indigestion. Diroximel fumarate is a product of Biogen Inc. and Alkermes plc. Consult prescribing information for important information on potential risks and predosing tests and evaluations.
FDA approves insulin glargine for adult, pediatric patients with type 1 and type 2 diabetes mellitus
Sanofi's insulin glargine (Toujeo) 300 units/mL received expanded approval to include the treatment of pediatric patients 6 years of age and older with type 1 diabetes mellitus (T1DM) and type 2 diabetes mellitus (T2DM). Previously, insulin glargine was indicated for use only in adults 18 year of age and older.
The FDA based the approval on results of the EDITION JUNIOR trial, which compared insulin glargine to Gla-100 in 463 patients ages 6 to 17 years with T1DM for at least 1 year. The primary end point was met: comparable decreases in hemoglobin A1C (A1C) from baseline for 6 months. Results showed an adjusted mean change from baseline in A1C of -0.386% with insulin glargine 300 units/mL versus -0.404% with insulin glargine 100 units/mL.
A similar percentage of patients experienced one or more events of severe and/or documented hypoglycemia. Numerically, the percentage of patients who experienced severe hypoglycemia or had one or more events of hyperglycemia with ketosis was lower with insulin glargine 300 units/mL versus insulin glargine 100 units/mL.
Insulin glargine is dosed once daily.
FDA warns about respiratory depression with gabapentin, pregabalin
Serious breathing difficulties may occur in patients using gabapentin (Neurontin, Gralise, Horizant) or pregabalin (Lyrica, Lyrica CR) who have respiratory risk factors, including use of opioid pain medications and other drugs that depress the central nervous system (CNS), and conditions including chronic obstructive pulmonary disease, the FDA warns. There is less evidence supporting the risks of serious breathing difficulties in healthy individuals taking gabapentinoids alone.
"Healthcare professionals should start gabapentinoids at the lowest dose and monitor patients for symptoms of respiratory depression and sedation when co-prescribing gabapentinoids with an opioid or other CNS depressant such as a benzodiazepine," the FDA notes. Patients with underlying respiratory disease and older adult patients are at an increased risk and should be managed similarly.
Pairing an opioid with any CNS depressant-a gabapentinoid, benzodiazepine, sedating antidepressant, sedating antipsychotic, antihistamine, or other product-increases the risk of respiratory depression. Shifting treatment from one CNS depressant to another may pose similar risks. "Be aware of the potential additive effects of all these CNS depressants and plan accordingly," the FDA warns.