Med Check

FDA Approves First Generic of Abilify

In April, the Food and Drug Administration (FDA) approved the first generic versions of Abilify (aripiprazole), indicated for schizophrenia and bipolar disorder.

The generics have been approved in multiple strengths and dosage forms and will come with a boxed warning for increased risk of suicidal ideation in children, adolescents, and young adults taking antidepressants. The box warning also points out an increased risk of death associated with the off-label use of the drugs to treat behavioral problems in older people with dementia-related psychosis.

Generic medications approved by the FDA have the same high quality and strength as brand-name drugs.

Companies receiving FDA approval for generic versions of Abilify included Alembic Pharmaceuticals, Hetero Labs, Teva Pharmaceuticals, and Torrent Pharmaceuticals.

FDA Delays Launch of Shire’s ADHD Drug for Adults

Shire recently announced that it has reached an agreement with the FDA regarding a regulatory route for the company’s new drug to treat attention-deficit/hyperactivity disorder (ADHD) in adults.

According to Shire, clinical trials for its investigational product SHP465—an extended-release (16 hour) formulation of mixed amphetamine salts—will have to be carried out in children aged 6 to 17 in a short-term study so that the FDA can “better understand the potential effects of SHP465 on children with ADHD in the event of use in this population,” the company noted in a press statement.

Shire initially hoped to launch the product by the end of this year, but the new regulatory path will delay the launch to the end of 2017.

Results highlighted in a New Drug Application submitted to the FDA by Shire in 2014 showed SHP465 to have a statistically significant difference in effectiveness after 16 hours compared with placebo in adults with ADHD.

Pfizer Wins First Court Case Against Zoloft Birth-Defect Claims

In April, a St. Louis jury found Pfizer not liable for congenital abnormalities in a boy whose mother took Zoloft during her pregnancy.

The case—which had at stake more than $2.7 million in compensation to be awarded to the plaintiff’s family—was the first case to go to trial among more than 1,000 lawsuits claiming that use of the antidepressant during pregnancy poses risk for a variety of health problems in offspring, including cardiac and other birth defects.

Pfizer argued that it has kept the public abreast of safety issues concerning Zoloft, which is packaged with an FDA-approved label that warns against using the drug while pregnant. In addition, one of Pfizer’s lawyers, Beth Wilkson, J.D., said in court that the science from a comprehensive review “has never even suggested that birth defects were caused by Zoloft.”

Pfizer Settles Lawsuit Over PD Medications

Last month, Pfizer decided to settle a class-action suit brought by patients who claimed that the pharmaceutical giant did not adequately warn them that use of the Parkinson’s disease (PD) drugs Cabasar and Dostinex could potentially lead them to engage more in addictive behaviors—such as gambling, shopping, and sex.

The confidential settlement, said by the Financial Review to be for millions of dollars, involves 172 patients who took the medications between 1996 and 2010 to treat tremors associated with PD and restless leg syndrome. Many plaintiffs, according to the publication, claimed to have gambled away hundreds of thousands of dollars, amounting to their entire life saving, after taking the drugs despite having not pre-existing gambling problems.

The medicines work as a dopamine agonist, imitating the effects of dopaminergic innervation in brain, a process that is compromised in patients with PD. A study published last year in JAMA Internal Medicine found that “psychiatric side effects” of uncontrollable urges were common in at least 10 percent of patients taking medicine of this class.

According to the Financial Review, Eli Lilly and Aspen Pharmacare also settled with 32 patients in 2013 in similar case involving the dopamine agonist Permax.

Vermont Governor Demands Cheaper Prices for Naloxone

Gov. Peter Shumlin (D-Vt.) has called out Amphastar for overpricing its overdose antidote, naloxone, which is marketed to instantly reverse overdoses of heroin and opioid painkillers.

Since the FDA’s approval of the hand-held auto-injector kit of naloxone, several states have adopted the opioid antagonist as a first response to opioid overdose, stocking the medication in police cars and ambulances. But as demands increase, so has the price, according to Shumlin.

From March to April of this year, the price of naloxone in Vermont has jumped 62 percent, going from $113 for 10 doses to $183.

Shumlin is just the latest of state officials to complain about Amphastar prices for naloxone. In February, Ohio’s attorney general demanded that the company give police departments a $6-per-dose rebate after Amphastar raised the price to $28.50 per dose. New York was awarded a similar rebate and a promise by Amphastar to keep wholesale prices steady for a year.

The state of Vermont has been dispensing naloxone kits to first-aid responders since 2013—which has resulted in nearly 200 lives being saved.

“The soaring cost of naloxone threatens to thwart our progress,” Shumlin said in a letter to Amphastar demanding lower prices for naloxone. ■