Pharmaceutical companies, Lundbeck and ACADIA, announced advancements in getting new drugs that treat people with Parkinson’s on the market, while Teva announced a recall affecting a generic Parkinson’s drug.
On Sept. 2, Lundbeck announced the availability of NORTHERA, a drug approved by the Food and Drug Administration (FDA) in February for the treatment of orthostatic dizziness, lightheadedness, or the “feeling that you are about to black out” in adult patients with symptomatic neurogenic orthostatic hypotension (NOH). NOH is caused by primary autonomic failure, dopamine beta-hydroxylase deficiency, and non-diabetic autonomic neuropathy, and is a common symptom of Parkinson’s disease. Northera is the only therapy for this condition that is approved by the FDA.
While not endorsing the drug, PAN attended an FDA advisory committee meeting in January 2014 and asked the FDA to give serious consideration to the significantly debilitating nature of NOH and the unmet medical need in treating Parkinson’s.
To learn more about how to access NORTHERA, contact Lundbeck’s Northera Support Center at 844-601-0101 (Monday through Friday from 8 a.m. to 8 p.m. ET) or visit www.northera.com.
ACADIA also announced on Sept. 2 that the FDA has granted Breakthrough Therapy designation to NUPLAZID™ (pimavanserin) for the treatment of Parkinson’s disease psychosis.
The Breakthough Therapy designation was included in the 2012 Food and Drug Administration Safety and Innovation Act, a bipartisan bill that PAN actively worked on and supported. The Breakthrough Therapy designation was created to expedite the development and review of drugs that are intended to treat serious or life-threatening conditions. For indications without an approved therapy, drugs qualifying for this designation must show a substantial and clinically meaningful effect on an important outcome when compared with placebo. The Breakthrough Therapy designation is distinct from priority review, which can also be granted to the same drug if the relevant criteria are met.
According to an ACADIA press release, NUPLAZID completed a Phase III trial in Parkinson’s disease psychosis, which the FDA has agreed can serve as the basis, together with supportive data from other studies, for a New Drug Application (NDA). ACADIA plans to submit the NDA to the FDA near the end of this year.
Additionally, Teva Pharmaceutical Industries announced last week that it is recalling one lot of its generic Parkinson’s disease combination medication, carbidopa/levodopa, because it potentially contains too much of an active pharmaceutical ingredient making it “super potent.”
The recall affects 3,881 bottles of carbidopa/levodopa 25 mg/100 mg and the FDA announced that the lot number involved is 29C220 and the expiration date is November 2015.
PAN does not endorse individual diagnostic products, drugs, devices, or therapies or take a position that one product, drug, device, or therapy is preferable to another.