Steve Duffy, Digital Content Editor

The NDA includes data from two Phase 3 clinical trials (SUNRISE 1 and SUNRISE 2) which included approximately 2000 patients.

An NDA has been submitted to the FDA for a transdermal patch formulation of asenapine for the treatment of schizophrenia.

An authorized generic version of Evzio is expected to be available next year at a price of $178 per carton.

Perseris, an atypical antipsychotic, has an extended-release delivery system that releases sustained levels of risperidone over 1 month.

In the meeting documents, the panel presented a scenario which illustrated their concerns regarding potentially complex drug interactions that may occur in the population for which the drug is intended.

The training has information on how to use several products including a nasal atomizer, Narcan Nasal Spray and Evzio.

Psilocybin, the active ingredient in “magic mushrooms”, has been granted Breakthrough Therapy designation by the FDA for treatment-resistant depression.

Standard pen needles have an outer cover and removable inner needle cover, while safety pen needles have an outer cover and a fixed inner needle shield that is not removed before an injection.

Lumateperone, a first-in-class molecule, works via potent interactions at 5-HT2A receptors, serotonin transporters, and D1 receptors with indirect glutamatergic modulation.

The new plan will break out the current guidance into 4 separate guidances.

The NDA includes five Phase 3 studies in patients with treatment-resistant depression: 3 short-term studies, 1 withdrawal maintenance of effect study, and 1 long-term safety study.

Last year, the DEA proposed a 20% reduction in the manufacturing of controlled substances for 2018 compared to 2017.

The 7 treatments included in the study were amphetamines (including lisdexamfetamine), atomoxetine, bupropion, clonidine, guanfacine, methylphenidate, and modafinil.

Participants in the trial were randomized to receive Tonmya 5.6mg sublingually at bedtime for 12 weeks or placebo sublingual tablets.

An investigational treatment for major depressive disorder, AGN-241751, has been granted Fast Track designation by the FDA.

The FDA has released new guidance for drug developers that could potentially lead to the approval of a wider range of nonprescription drug products.

Gottlieb said “The charge to this new task force is to look for holistic solutions to addressing the underlying causes for these [drug] shortages.”

Through their predictive analytics, Cigna can identify customers most likely to suffer from an overdose and can prompt interventions.

CVS Pharmacy is now offering home delivery nationwide for prescription drugs, for a service charge of $4.99.

Electrical pulses are sent through small needles that are inserted in the ear to combat the early stages of detoxification, leading to stabilization.

Phase 3 clinical trials for lanabecestat (Eli Lilly and AstraZeneca), an investigational Alzheimer disease treatment, are being discontinued for futility.

Clinician attire is an important factor for a significant number of patients, and can influence the perception of care they receive.

Despite the widespread use of antidepressants for treating insomnia, the evidence for their effectiveness remains limited.

FDA Commissioner, Scott Gottlieb MD, said, “The FDA shares the goal of ensuring that American patients have access to quality and affordable care that meets their needs.”

The use of certain anticholinergic drugs may increase the risk of future dementia.

Results in the 202B and 202C trials showed that brexanolone achieved the primary endpoint of mean reduction from baseline in the Hamilton Rating Scale for Depression.

ALKS 5461 consists of a fixed-dose combination of buprenorphine and samidorphan.

The DASH diet and the Mediterranean diet have been ranked as joint ‘Best Overall’ diet.

The CDC has been informed of words that are no longer allowed to be used in documents.

Research conducted by the AMA highlights the seriousness of cyberattacks in healthcare.