Med Check

The Food and Drug Administration (FDA) in January approved a supplemental New Drug Application for Latuda (lurasidone HCl) for the treatment of schizophrenia in adolescents aged 13 to 17 years.

Latuda is already approved in the United States for the treatment of adults with schizophrenia and for the treatment of adults with major depressive episodes associated with bipolar I disorder (bipolar depression) as monotherapy and as adjunctive therapy with lithium or valproate.

According to a statement on the website of Sunovion, which manufactures Latuda, the approval is based on results from a randomized, double-blind, placebo-controlled, six-week study in which adolescent patients with schizophrenia received fixed doses of Latuda 40 mg/day, Latuda 80 mg/day, or placebo.

At the study endpoint, Latuda 40 mg/day and 80 mg/day were associated with statistical and clinical improvement in symptoms of schizophrenia compared with placebo. Latuda was also generally well tolerated with limited effects on weight and metabolic parameters.

Amorsa Therapeutics Inc. announced in January that it will be teaming up with Janssen Pharmaceuticals Inc. to develop and commercialize a novel small molecule drug candidate for treatment-resistant depression based on Amorsa’s proprietary ketamine analog technology.

As part of a research, option, and license agreement between the companies, Amorsa will manage the preclinical development program, while Janssen will assume responsibility for subsequent clinical, regulatory, and commercial development of the licensed drug candidate.

Newron Pharmaceuticals in January announced positive results from a phase 2a trial of the company’s novel sodium channel blocker evenamide (NW-5309) as an add-on treatment for patients with schizophrenia. Patients who took the medication daily with risperidone or aripiprazole for four weeks experienced a reduction in schizophrenia symptoms, the company reported.

The randomized, controlled trial included 89 patients with schizophrenia, who were experiencing breakthrough psychotic symptoms while on risperidone (mean dose: 4.2 ± 2.0 mg/day; n=70) or aripiprazole (mean dose: 19.7 ± 7.0 mg/day; n=19). Patients were randomly assigned to receive twice daily evenamide (15 to 25 mg) or placebo, in addition to their current antipsychotic for four weeks.

Patients taking adjunctive evenamide showed greater improvements in symptoms (as assessed by the Positive and Negative Syndrome Scale) as well as functioning (as assessed by the Strauss-Carpenter Level of Functioning scale) compared with those taking adjunctive placebo.

Evanamide was generally well tolerated, with somnolence, insomnia, and headache among the most commonly reported adverse effects.

The U.S. Department of Justice (DOJ) announced in January that McKesson Corp., one of the nation’s largest drug distributors, has agreed to pay a $150 million fine for alleged violations of the Controlled Substance Act. The nationwide settlement also requires that the company suspend sales of controlled substances from distribution centers in Colorado, Florida, Michigan, and Ohio for several years.

In 2008, McKesson paid a $13.25 million civil penalty over similar violations.

“In this case, the government alleged again that McKesson failed to design and implement an effective system to detect and report ‘suspicious orders’ for controlled substances distributed to its independent and small chain pharmacy customers—i.e., orders that are unusual in their frequency, size, or other patterns,” a DOJ release stated. “From 2008 until 2013, McKesson supplied various U.S. pharmacies an increasing amount of oxycodone and hydrocodone pills, frequently misused products that are part of the current opioid epidemic.”

In response to the news, McKesson Chair and CEO John H. Hammergren stated in a press release, “Pharmaceutical distributors play an important role in identifying and combating prescription drug diversion and abuse. We continue to significantly enhance the procedures and safeguards across our distribution network to help curtail prescription drug diversion while ensuring patient access to needed medications.”

H. Lundbeck A/S announced in January that it had secured a license to develop multiple CNS products using Ossainix’s variable new antigen receptor (VNAR) antibody technology.  

VNAR is a shark-derived antibody that binds to the blood-brain barrier transferrin receptor. By fusing therapeutic agents targeting molecules in the brain to the VNAR, therapies can be shuttled across the blood-brain barrier. The technology has been successfully tested in mice.

“This new technology may pave the way for many new and better treatments of brain diseases, even some that can’t be treated today due to the BBB keeping therapeutic drugs from entering the brain,” Lundbeck reported on its website. “However, as the research is still in a quite early phase, there is a risk that it may not be applicable for use in humans. We will now refine the Ossianix technology with the aim of hopefully testing it in humans.” ■