Med Check

FDA Approves New Injection Site for Abilify Maintena

In July, the Food and Drug Administration (FDA) approved injection of Abilify Maintena (aripriprazole) in the deltoid arm muscle. Health care providers will now have the option to administer the long-acting injectable antipsychotic in the gluteal or deltoid muscle when treating patients with schizophrenia.

The approval of the deltoid as an injection site was based on two studies involving a total of 178 patients with schizophrenia aged 18 to 64 who were selected to receive a 400 mg injection of Abilify Maintena in the gluteal muscle or the deltoid muscle. The studies compared the safety, tolerability, and pharmacokinetics of Abilify Maintena administered in the deltoid muscle with that of having the drug administered in the gluteal muscle. Safety and effectiveness of the drug between the two injection sites were found to be comparable.

Abilify Maintena is a D2 partial agonist administered to patients once a month. It was originally approved by the FDA for only gluteal injection in February 2013. Label changes incorporating deltoid administration for Abilify Maintena are scheduled to take place in the fall.

FDA Issues Warning Over Brintellix, Brilinta Confusion

On July 30, the FDA issued a warning to health care professionals and patients concerning reports of confusion between the antidepressant Brintellix (vortioxetine) and the anti-blood clotting medication Brilinta (ticagrelor), which has resulted in the wrong medication being prescribed or dispensed.

The FDA has determined that the main reason for the confusion between the two medications—with extremely different indications—is the similarity in the marketed names of the drugs. While the selective serotonin reuptake inhibitor Brintellix is used to treat major depressive disorder, Brilinta is an antiplatelet, anti-blood clotting medication that is used to lower the risk of recurrent heart attacks or death from a heart problem after a heart attack or severe chest pain.

To reduce the risk of name confusion, the FDA recommends that health care professionals include the generic name of the medication (e.g., vortioxetine) in addition to the brand name and the indication for use when prescribing the medication. The FDA also recommends that patients check their prescriptions to ensure that the correct medication was dispensed.

At the time of the FDA announcement, no reports regarding the name confusion had indicated that any patients had ingested the wrong medication; however, reports of prescribing and dispensing errors continue, according to the agency.

FDA to Review Cognitive Claims Linked to Brintellix

Last month, the FDA agreed to review a Supplemental New Drug Application (sNDA) submitted by H. Lundbeck A/S and Takeda Pharmaceutical Company regarding the benefits of Brintellix (vortioxetine) as it relates to the drug’s ability to reduce cognitive dysfunction in adults with major depressive disorder (MDD). The companies are hoping to have these claims added to the label of the selective serotonin reuptake inhibitor next year.

The sNDA is primarily based on the FOCUS and CONNECT studies, which were specifically designed to examine the effect of Brintellix on certain aspects of cognitive function in adult patients with MDD. The CONNECT study showed that Brintellix had a competitive advantage in reducing cognitive dysfunction in MDD patients over Eli Lilly and Co.’s antidepressant Cymbalta (duloxetine).

The FDA will review all submitted data supporting the cognitive benefits for Brintellix and decide if a label change is warranted by March 28, 2016.

According to previous studies, cognitive symptoms were reported by patients with MDD up to 94 percent of the time during major depressive episodes.

Lilly’s Alzheimer’s Drug Found To Delay Disease Progression

People with mild Alzheimer’s disease who took Eli Lilly and Co.’s drug solanezumab earlier in the course of their disease saw benefits compared with patients who start the medication later on, according to data presented by the company at the 2015 Alzheimer’s Association International Conference in held in Washington, D.C., in July.

The study included 1,300 patients with mild-to-moderate symptoms of Alzheimer’s disease, who were randomly given solanezumab intravenously (400 mg/month) or placebo for 18 months. After this period, all patients, including those who initially took placebo, were administered solanezumab (400 mg/month).

At the end of the first half of the study, those taking solanezumab performed significantly better on cognitive and daily functional assessments— Alzheimer’s Disease Assessment Scale Cognitive subscale and Alzheimer’s Disease Cooperative Study–Activities of Daily Living functional scale, respectively—than those who took placebo.

Two years later, the cognitive differences between the two groups remained despite the fact both groups had received treatment with solanezumab for at least two years.

Lilly plans to confirm these findings with follow-up trials.

Roche Revives Alzheimer’s Drug For Another Phase 3 Endeavor

Roche Pharmaceuticals has plans to once again test its Alzheimer’s treatment gantenerumab, which failed in an initial phase 3 trial near the end of 2014. The drug is an antibody designed to rid the brain of beta-amyloid proteins, which form plaques that many researchers believe are at the center of Alzheimer’s disease.

In an interview with Reuters, a spokesperson for Roche said the company has moved beyond its previous clinical failures with the antibody and is currently “developing novel approaches to implement higher doses” of gantenerumab for new phase 3 trials to be carried out in patients with Alzheimer’s.

Roche said that it has requested feedback from global regulators on its plans for new studies, but the company is not disclosing when these studies will be initiated. ■