Med Check

This summer, the FDA approved a second extended-release/long-acting opioid analgesic (ER/LA) with “abuse-deterrent” properties—Targiniq ER (oxycodone hydrochloride and naloxone hydrochloride).

“The FDA is committed to combatting the misuse and abuse of all opioids, and the development of opioids that are harder to abuse is needed in order to help address the public-health crisis of prescription drug abuse in the U.S.,” said Sharon Hertz, M.D., deputy director of the Division of Anesthesia, Analgesia, and Addiction Products in the FDA’s Center for Drug Evaluation and Research.

When crushed and snorted, or crushed, dissolved, and injected, the naloxone in Targiniq ER blocks the euphoric effects of oxycodone, making it less desirable to abusers than oxycodone alone. Naloxone is commonly used to reverse the effects of opioid overdose. Because Targiniq ER has properties that are expected to deter, not totally prevent, abuse of the drug, the FDA recommends that it should be prescribed only to people for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient pain management.

The safety and effectiveness of the new ER/LA opioid analgesic was evaluated in a clinical trial of 601 people with low back pain. Results from studies testing abuse liabilities indicated that the abuse deterrent features of Targiniq ER relate particularly to certain types of abuse, such as snorting and injecting. The most common side effects reported were nausea and vomiting.

The FDA is requiring postmarketing studies to further assess the effects of the abuse-deterrent features of the medication, as well as the serious risks of misuse, abuse, increased sensitivity to pain, addiction, overdose, and death associated with long-term use beyond 12 weeks.

Targiniq ER is manufactured by Purdue Pharma.

In late July, Philadelphia County Court of Common Pleas Judge Arnold New reiterated that he will not reverse his decision rejecting plaintiffs’ attempt to seek punitive damages against Johnson & Johnson for inadequate warning labels for the antipsychotic Risperdal, which allegedly can cause development of gynecomastia in adolescent males (Psychiatric News, December 4, 2013).

New issued the initial decision denying punitive damages in May, ruling that the New Jersey–based company falls under the New Jersey Product Liability Act—a provision barring punitive damages in cases involving medications that have been approved by the FDA.

The plaintiffs responded in June, arguing that New Jersey’s ban on punitive damages is irrelevant to their suits, because many of them had been treated with Risperdal for uses that were not approved by the FDA. However, New stood by his earlier decision that these plaintiffs cannot seek punitive damages.

After the judge reiterated his decision, Bernstein Liebhard, a law firm representing some of the plaintiffs, released a statement saying, “It is important that all plaintiffs involved in this litigation understand that this latest decision does not in any way bar them from seeking compensatory damages. . . lawsuits will continue to move forward.”

Nearly 600 individual cases have been filed against Johnson & Johnson for allegedly withholding information on the potential adverse risks associated with taking Risperdal. According to court records, Johnson & Johnson’s Janssen Pharmaceuticals subsidiary, which makes Risperdal, has reached settlements in approximately 80 Risperdal suits in Philadelphia.

Last month, Baltimore-based biopharmaceutical company Cerecor announced that it has secured half of the $32 million proposed for a phase 2 trial of its new therapy for major depressive disorder (MDD).

The product, CERC-301, is a selective inhibitor for the subunit NR2B located on the glutamate-related NMDA receptor. CERC-301 will be tested as a once-a-day adjunctive therapy for severe MDD. The concept of the new therapy is to block NMDA pathways in a rapid manner similar to that of ketamine—an NMDA antagonist—with fewer severe side effects, such as hallucinations.

Cerecor plans to have phase 2 data available on 135 subjects by the end of this year.

Sun Pharmaceuticals has voluntarily recalled its version of the antidepressant venlafaxine hydrochloride because the drug is not properly dissolving in the body.

“Stability results found the product did not meet the drug release dissolution specifications,” stated the Food and Drug Administration (FDA) in an online enforcement report issued July 9. Dissolution tests are commonly conducted to help predict how a drug performs inside the body.

The FDA has categorized the recall as class II, indicating that use of or exposure to the product may result in temporary or medically reversible adverse health consequences.

The India-based manufacturer now has to withdraw more than 41,000 bottles of the serotonin-norepinephrine reuptake inhibitor, which is a generic version of Pfizer’s Effexor XR.

The latest recall is one more in Sun Pharma’s series of mishaps in 2014. In April, the company recalled a chemotherapy drug for sterility issues, which followed withdrawal of more than 2,500 bottles of an antidiabetes drug in January due to reports of an unrelated medication being found in the bottles. And in May, the FDA banned all imports from the company’s Karkhadi, India, plant over underreporting of batch failures.

Pharmaceutical giant Roche released mixed results for the phase 2 clinical trial of its Alzheimer’s disease (AD) therapy candidate crenezumab—leaving the company to decide whether it should proceed with phase 3 studies.

Roche tested the drug against placebo for 18 months in 431 patients with mild to moderate AD.

The results—presented in July at the Alzheimer’s Association International Conference in Copenhagen—showed that while crenezumab failed to reduce cognitive decline compared with placebo, it was capable of reducing cognitive decline by 35 percent and global functional decline by 19.6 percent in patients with mild AD.

Crenezumab is a monoclonal antibody that binds to amyloid-beta protein buildup to stimulate the immune system to break down the clumped material. Unlike other therapies targeting AD, crenezumab has yet to run into dose-limiting side effects.

Roche is collaborating with the National Institutes of Health to test crenezumab in 100 patients who have yet to show signs of AD but carry a genetic profile that predisposes them to the disease. ■