The US Court of Appeals for the Second Circuit granted the Actavis' motion to expedite its appeal of a lower court ruling requiring company to continue distribution of Namenda (memantine HCl) immediate-release tablets. The company's motion asked the Court to expedite the briefing of the case so that the Court could issue its decision by February 16, 2015. The Court denied the company's request for a stay of the lower court ruling while the appeal is ongoing.
"We are pleased that the Appeals Court has agreed to hear this on an accelerated basis and optimistic that the Court will overturn the lower court's unprecedented ruling," said Brent Saunders, chief executive officer, and president of Actavis.
On Monday, December 15, Judge Robert Sweet of the United States District Court for the Southern District of New York (New York City) issued a preliminary injunction requiring Actavis to continue distribution of Namenda immediate-release tablets.
Actavis reiterated that the District Court ruling will have no impact on its ability to continue focussing its resources on transitioning patients to the convenient and innovative once-daily Namenda and that the Company is prepared to manage its business in a way that provides the least disruption in its ability to support the marketplace and minimise any financial impact.
Namenda (memantine HCl) extended release capsules are a higher dose, once-daily formulation of Namenda immediate release indicated for the treatment of moderate to severe dementia of the Alzheimer's type. Its mechanism of action focusses on the glutamate pathway, a target for the treatment of Alzheimer's disease. The efficacy and safety of Namenda was established in a 24 week, randomised, double-blind, placebo-controlled trial of 677 outpatients on a stable dose of acetylcholinesterase inhibitors (AChEI).
Namenda 28 mg plus an AChEI demonstrated statistically significant improvement in cognition and global function compared to placebo plus an AChEI. Cognition was measured by the Severe Impairment Battery Scale (2.6 unit mean difference). Global function was measured by the Clinician's Interview-Based Impression of Change Scale (0.3. unit mean difference).
There is no evidence that Namenda or an AChEI prevents or slows the underlying disease process in patients with Alzheimer's disease.
The recommended starting dose of Namenda is 7 mg once daily. The recommended target dose is 28 mg once daily. The dose should be increased in 7 mg increments to 28 mg once daily. The minimum recommended interval between dose increases is one week and only if the previous dose has been well tolerated. The maximum recommended dose is 28 mg once daily.
It is recommended that a patient who is on a regimen of 10 mg twice daily of Namenda tablets be switched to Namenda 28 mg once-daily capsules the day following the last dose of a 10 mg Namenda tablet. There is no study addressing the comparative efficacy of these 2 regimens.
It is recommended that a patient with severe renal impairment who is on a regimen of 5 mg twice daily of Namenda tablets be switched to Namenda XR 14 mg once-daily capsules the day following the last dose of a 5 mg Namenda tablet.
Namenda should be administered with caution to patients with severe hepatic impairment.
A target dose of 14 mg/day is recommended in patients with severe renal impairment (creatinine clearance of 5-29 mL/min, based on the Cockcroft-Gault equation).