FDA Approves Two-Month Aripiprazole Injectable
The Food and Drug Administration (FDA) has approved a two-month formulation of Aristada (aripiprazole lauroxil), a long-acting injectable antipsychotic for the treatment of schizophrenia. Aristada is currently approved in both once monthly (at 441 mg, 662 mg, or 882 mg) and once every six weeks (at 882 mg) injections. The new two-month injection will be dosed at 1,064 mg.
“As the first and only long-acting atypical antipsychotic approved in three dosing durations and with the ability to initiate treatment at any dose or duration, Aristada provides a range of options to help clinicians tailor treatment to the individual needs of their patients,” said Elliot Ehrich, M.D., executive vice president for research and development of Aristada manufacturer Alkermes, in a press release.
The efficacy of the longer-form injectable was demonstrated in a randomized, open-label trial of 140 individuals with stable schizophrenia. The study showed that patients who received the 1,064 mg dose every two months had similar safety and pharmacokinetic profiles as those receiving 441 mg of aripiprazole monthly or 882 mg every six weeks.
Endo Pharmaceuticals Pulls Opana From Market at FDA’s Request
On July 6, Endo Pharmaceuticals agreed to voluntarily remove its opioid pain medication, reformulated Opana ER (oxymorphone hydrochloride), from the market. The removal followed a formal withdrawal request by the FDA in June.
“This is the first time the agency has taken steps to remove a currently marketed opioid pain medication from sale due to the public health consequences of abuse,” the agency stated in a press release.
The agency based its decision on postmarketing data that revealed that Opana ER was being abused via injection following the product’s reformulation. (Opana ER was reformulated to make the drug resistant to manipulation for abuse by snorting or injecting.) Injection abuse of the medication has been associated with a serious outbreak of HIV and hepatitis C, as well as cases of the blood disorder thrombotic microangiopathy, according to the agency.
In March, a joint FDA advisory committee voted 18-8 that the benefits of reformulated Opana ER no longer outweighed its risks.
Endo iterated in a statement that despite the voluntary withdrawal, it remains confident in data demonstrating Opana’s safety, efficacy, and favorable risk-benefit profile when used as intended.
FDA Approves First XR Orally Disintegrating Methylphenidate Tablet
The FDA in June approved Cotempla XR-ODT, the first extended-release, orally disintegrating methylphenidate tablet for the treatment of attention-deficit/hyperactivity disorder (ADHD) in pediatric patients aged 6 to 17.
The approval of Cotempla XR-ODT was based in part on the results of a phase 3 clinical trial of children in a laboratory classroom setting, according to Neos Therapeutics Inc., the manufacturer of the medication.
The study found that children who took Cotempla XR-ODT experienced significantly improved ADHD symptoms compared with placebo; effects were evident after one hour and lasted through 12 hours. The adverse-event profile for Cotempla XR-ODT was consistent with the established safety profile for other extended-release methylphenidate products.
Cotempla XR-ODT will be commercially available beginning this fall, according to Neos. ■
