Skip to Content

Weekly Drug News Round Up - July 15, 2015

Rexulti Approved for Schizophrenia and as Add-On Treatment for Depression

Clinicians should see the label for significant CYP enzyme drug interactions that affect the dose of Rexulti Read More...

The U.S. Food and Drug Administration has approved Rexulti (brexpiprazole) as treatment for adults with schizophrenia and as an adjunct to treatment for major depressive disorder (MDD). Rexulti is a serotonin-dopamine activity modulator (SDAM) and second-generation version of aripiprazole (Abilify), with a reduced incidence of akathisia (restlessness). Common side effects differed in schizophrenia and MDD treatment groups but included akathisia, diarrhea, nausea, weight gain, headache and somnolence. Oral tablets will be available in six strengths: 0.25, 0.5, 1, 2, 3 and 4 mg. Rexulti will be co-marketed by Lundbeck and Otsuka and is expected to launch in August 2015.

Envarsus XR: A Once-A-Day Tacrolimus FDA-Approved

After a transplant, a patient must receive immunosuppression as lifelong therapy Read More...

The FDA has approved Veloxis Pharmaceutical’s Envarsus XR (tacrolimus extended-release tablets) for the prevention of kidney transplant rejection in patients who prefer to convert from twice daily tacrolimus to Envarsus XR taken only once-a-day. In Phase III studies, Envarsus XR dosed once daily demonstrated significantly higher bioavailability compared to the current leading transplant drug, Prograf (immediate release tacrolimus), dosed twice-daily. Envarsus XR extended-release tablets are not interchangeable or substitutable with other tacrolimus extended-release or immediate-release products. Envarsus XR has received orphan drug designation in the U.S., and Veloxis expects Envarsus XR to be available commercially in 4Q 2015.

FDA Approves Iressa for First-Line Treatment of Metastatic Non-Small Cell Lung Cancer

A companion diagnostic test called the therascreen EGR RGQ PCR Kit helps to target the right patients for treatment Read More...

The U. S. Food and Drug Administration has approved AstraZeneca’s gefitinib (Iressa) for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors contain specific types of epidermal growth factor receptor (EGFR) gene mutations, as detected by an FDA-approved test. Mutations in the EGFR gene are present in about 10 percent of NSCLC tumors. Iressa is a kinase inhibitor that blocks the proteins that promote the development of cancerous cells with certain EGFR mutations. In studies with Iressa given at 250 mg once daily, tumors shrank in about 50 percent of patients and lasted an average of six months.

FDA Strengthens NSAID Warnings for Heart Attack and Stroke

The risk of heart attack and stroke with NSAIDs, either of which can lead to death, was first described in 2005 Read More...

FDA is strengthening an existing warning that the use of prescription and over-the-counter (OTC) nonsteroidal anti-inflammatory drugs (NSAIDs) can increase the risk of a heart attack or stroke. Revisions include warnings about the relation of length of use and dose of NSAID to these serious events, relative risk with individual NSAIDs, and other important relationships between drug use and risk of heart attack or stroke which can be viewed here. Patients taking NSAIDs should seek medical attention immediately if they experience symptoms such as chest pain, trouble breathing, weakness in one side of their body, or slurred speech.

More NSAID Bad News: Risk of Brain Bleed With Antidepressants

SSRI antidepressants can hinder blood cells called platelets from normal blood clotting Read More...

Not only has the FDA updated NSAIDs labels about the risk of heart attack and stroke, a new study published this week in BMJ suggests certain antidepressants combined with NSAIDs may elevate risk for intracranial hemorrhage (bleeding). However, the incidence was low; only 5.7 bleeds per 1,000 patients (0.5 percent) taking the drugs over one year. NSAIDs include over-the-counter pain relievers such as aspirin, ibuprofen (Motrin, Advil) and naproxen (Aleve). Some SSRI antidepressants - which include widely prescribed drugs such as Paxil and and Zoloft, can increase the risk for bleeding due to platelet interference and may lead to a partial explanation; however, experts suggest further studies.