Med Check
Lilly Halts Study on Beta Secretase Inhibitor
Eli Lilly and Co. announced June 13 that it has discontinued its phase 2 study (BACC) for LY2886721, a beta secretase (BACE) inhibitor, being investigated as a treatment for its potential to slow the progression of Alzheimer’s disease. The termination was due to the appearance of abnormal liver biochemical tests, which were identified as part of routine monitoring. Lilly said it believes the abnormal liver biochemical tests are not related to the BACE mechanism, and the company continues to be interested in developing BACE inhibitors for patients with Alzheimer’s disease. Lilly will conduct additional data evaluations before determining next steps for the entire LY2886721 clinical development program and will continue to monitor participants with abnormal liver values.
MedWatch Program Celebrates 20 Years With New Consumer Form
The Food and Drug Administration (FDA) is celebrating the 20th anniversary of its MedWatch program, which provides important safety information associated with FDA-regulated products, with a new form intended to encourage more consumer participation.
Under MedWatch, health care professionals and consumers submit reports to the FDA when they find a problem with a drug, medical device, biologic, or other FDA-regulated product. Over the years, most of the voluntary MedWatch forms have been submitted by health care professionals, but recently consumers have been increasingly interested in participating in the program. The new, consumer-friendly MedWatch reporting form is a response to consumer concerns that the form is too technical. FDA officials worked with groups such as AARP, Consumers Union, and the National Women’s Health Network in developing the new form. Also being introduced is a new Web-based learning tool, called MedWatchLearn, which is designed to educate students, health care professionals, and consumers on how to complete a report properly. MedWatchLearn also provides examples of quality reports that include critical information to help FDA evaluate the event or product-quality complaint.
Canada Approves Aripiprazole As MDD Add-On
Bristol-Myers Squibb Canada announced June 6 that Abilify (aripiprazole) has received an additional approval from Health Canada as an adjunct treatment for major depressive disorder (MDD) in adults who had an inadequate response to prior antidepressant treatments during the current episode. When used with an antidepressant, Abilify has been shown to improve symptoms in adults with MDD who had an inadequate response to at least two trials with antidepressants during the current episode. It is the first add-on treatment for MDD to be approved in Canada. The Health Canada approval is based on results from three six-week, double-blind, randomized, placebo-controlled, multicenter studies (n=1,088). The results from all three studies indicated significant improvement in depressive symptoms in adult patients with a primary diagnosis of MDD who had experienced an inadequate response to monotherapy with two or more antidepressants. Significant improvements in depression symptoms were seen in the second week of add-on treatment with Abilify, when compared with the control subjects.
Abilify is also the first Health Canada–approved antipsychotic for adolescents (schizophrenia patients aged 15 to 17 and for acute treatment of manic or mixed episodes in bipolar I disorder as monotherapy in adolescent patients aged 13 to 17). It was first approved in July 2009 by Health Canada for treatment of schizophrenia and related psychotic disorders in adults and for treatment of manic or mixed episodes in bipolar I disorder in adults as acute monotherapy or co-therapy with lithium or divalproex sodium when there is an insufficient acute response to these agents alone.
Walgreens Reaches Settlement for $80 Million
On June 11, Illinois-based pharmacy chain Walgreens said it had reached an agreement with the Drug Enforcement Administration (DEA) and the Department of Justice, which settles and resolves all administrative and civil matters arising out of DEA’s concerns relating to the distribution and dispensing of controlled substances out of a Jupiter, Fla., Walgreens distribution center. The Walgreens Jupiter is one of 12 distribution centers owned and operated by the Walgreens Corporation, which is also the parent company of more than 7,800 Walgreens retail pharmacies in the United States. Walgreens Jupiter distributes controlled substances exclusively to Walgreens pharmacies located on the East Coast. On April 4, 2012, the DEA Miami Field Division served an Administrative Inspection Warrant on Walgreens Jupiter and its top six retail pharmacies in Florida after it became aware of “an unprecedented number” of record-keeping and dispensing violations, most related to dispensing of oxycodone.
Under the terms of the agreement, Walgreens will pay $80 million. The agreement resolves all pending litigation and requires Walgreens to surrender its DEA registrations at only six of its more than 800 Florida pharmacies until May 2014 and at its Jupiter distribution center until September 2014. “As part of the agreement with DEA and our continuing desire to work with DEA to combat prescription drug abuse, we have identified specific compliance measures—many of which Walgreens has already taken—to enhance our ordering processes and inventory systems; to provide our team members with the tools, training, and support they need to ensure the appropriate dispensing of controlled substances; and to improve collaboration across the industry,” said Kermit Crawford, Walgreens’ president of pharmacy, health, and wellness. ■
