Diana Ernst, RPh

The supplemental New Drug Application (sNDA) for Emgality (galcanezumab-gnlm; Lilly) has been granted Priority Review by the Food and Drug Administration (FDA) for the preventive treatment of episodic cluster headache in adults.

Inbrija, the first inhaled levodopa, has been made available by Acorda Therapeutics for the intermittent treatment of OFF episodes in patients with Parkinson disease treated with carbidopa/levodopa.

The FDA has accepted for review the New Drug Application for a novel oral fumarate candidate, diroximel fumarate, for the treatment of relapsing forms of multiple sclerosis.

The FDA has accepted for Priority Review the supplemental Biologics License Application for Soliris for use in patients with neuromyelitis optica spectrum disorder.

Over 1400 clinical trials and research studies were reviewed by a panel of 13 experts to develop the new guideline.

Currently, there are no approved therapies for the treatment of MSA, a rare progressive neurodegenerative disease.

The Mediterranean diet was ranked as the best diet overall for 2019.

A recent report from the CDC identified the 10 drugs most frequently mentioned in overdose deaths.

Positive topline results were announced from a Phase 3 trial evaluating the safety and efficacy of rimegepant Zydis orally dissolving tablet for the acute treatment of migraine.

In animal studies, the treatment was associated with improvement in both motor and cognitive function.

According to a Phase 3b open-label study, Ocrevus may interfere with the effectiveness of non-live vaccines.

The FDA has issued a safety communication regarding the risks associated with implanted pumps for intrathecal administration of pain medications.

The authors found that the compounds known as phenylindanes inhibited the aggregation of the amyloidgenic proteins beta-amyloid and tau.

The Food and Drug Administration (FDA) approved the treatment in June 2018, making it the first prescription pharmaceutical formulation of highly-purified, plant-derived cannabidiol, as well as the first treatment indicated for patients with Dravet syndrome.

To investigate the link between organic food consumption and cancer risk, study authors conducted a population-based prospective cohort study among French adults.

Recommendations on the use of these agents in this patient population were published in a Views and Perspectives paper in the journal Headache.

The approval was based on data from the Phase 3 NEURO-TTR study (N=173) which randomized patients with polyneuropathy caused by hATTR amyloidosis to Tegsedi or placebo.

The open-label safety study included patients from 3 Gocovri dyskinesia efficacy trials (N=223) and evaluated the long-term safety and tolerability of the treatment.

In patients with chronic sciatica, gabapentin was associated with a greater reduction in leg pain intensity and fewer side effects compared with pregabalin.

The FDA is not bound by the Committee’s recommendation but takes it into consideration when making its decision.

The primary outcome measure of the study was the frequency of any adverse psychiatric effect observed during treatment with one of these agents.

The approval was based on data from 3 randomized, double-blind, placebo-controlled trials (EVOLVE-1, EVOLVE-2, REGAIN) in patients with either episodic or chronic migraine.

In the PREVENT study, the safety and efficacy of Soliris was compared to placebo in patients with AQP4 auto antibody-positive NMOSD (N=143).

Cerdelga is indicated for the long-term treatment of adult patients with Gaucher disease type 1 who are CYP2D6 extensive metabolizers, intermediate metabolizers, or poor metabolizers as detected by an FDA-cleared test.

DMD is predominately caused by out-of-frame deletions in the dystrophin gene, which results in absent or defective dystrophin protein, leading to progressive and irreversible muscle function loss.

The safety and efficacy of clobazam monotherapy in patients with new-onset focal or generalized seizures was investigated in a new Cochrane systematic review.

The FDA has approved an abbreviated New Drug Application for Vigadrone, the generic alternative to Sabril powder for oral solution.

Teva has decided to discontinue part of the ENFORCE Phase 3 clinical development program for fremanezumab.

The FDA has granted Breakthrough Therapy designation to Lenti-D for the treatment of patients with cerebral adrenoleukodystrophy.

These Medication Guides should be provided the first time an outpatient receives a GBCA injection at an MRI center; hospital patients are not required to receive a Medication Guide.