FDA approves drug to treat Parkinson's disease

FDAThe U.S. Food and Drug Administration has approved Xadago (safinamide) tablets as an add-on treatment for patients with Parkinson's disease who are currently taking levodopa/carbidopa and experiencing "off" episodes. An "off" episode is a time when a patient’s medications are not working well, causing an increase in Parkinson's symptoms, such as tremor and difficulty walking.

"Parkinson's is a relentless disease without a cure," said Eric Bastings, M.D., deputy director of the Division of Neurology Products in the FDA's Center for Drug Evaluation and Research. "We are committed to helping make additional treatments for Parkinson’s disease available to patients."

An estimated 50,000 Americans are diagnosed with Parkinson's disease each year, according to the National Institutes of Health, and about one million Americans have the condition. The neurological disorder typically occurs in people over age 60, though it can occur earlier, when cells in the brain that produce a chemical called dopamine become impaired or die. Dopamine helps transmit signals between the areas of the brain that produce smooth, purposeful movement - such as eating, writing, and shaving. Early symptoms of the disease are subtle and occur gradually. In some people, Parkinson's disease progresses more quickly than in others.

The efficacy of Xadago in treating Parkinson's disease was shown in a clinical trial of 645 participants who were also taking levodopa and were experiencing "off" time. Those receiving Xadago experienced more beneficial "on" time, a time when Parkinson’s symptoms are reduced, without troublesome uncontrolled involuntary movement (dyskinesia), compared to those receiving a placebo. The increase in "on" time was accompanied by a reduction in “off” time and better scores on a measure of motor function assessed during "on" time than before treatment.

In another clinical trial of 549 participants, the participants adding Xadago to their levodopa treatment had more "on" time without troublesome uncontrolled involuntary movement compared to those taking a placebo, and also had better scores on a measure of motor function assessed during "on" time than before treatment.

Certain patients should not take Xadago. These include patients who have severe liver problems, or who take a medicine used to treat a cough or cold called dextromethorphan. It also should not be taken by patients who take another medicine called a monoamine oxidase inhibitor (MAOI) because it may cause a sudden severe increase in blood pressure, or by those who take an opioid drug, St. John’s wort, certain antidepressants (such as serotonin-norepinephrine reuptake inhibitors, tricyclics, tetracyclics, and triazolopyridines), or cyclobenzaprine, because it may cause a life-threatening reaction called serotonin syndrome.

The most common adverse reactions observed in patients taking Xadago were uncontrolled involuntary movement, falls, nausea, and trouble sleeping or falling asleep (insomnia).

Serious, but less common, risks include the following: exacerbated high blood pressure (hypertension); serotonin syndrome when used with MAOIs, antidepressants, or opioid drugs; falling asleep during activities of daily living; hallucinations and psychotic behavior; problems with impulse control/compulsive behaviors; withdrawal-emergent hyperpyrexia (fever) and confusion; and retinal pathology.

The FDA granted approval of Xadago to Newron Pharmaceuticals.

The FDA, an agency within the U.S. Department of Health and Human Services, promotes and protects the public health by, among other things, assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that emit electronic radiation, and for regulating tobacco products.

Most Popular Now

Making biological drugs with spider silk protein

Researchers at Karolinska Institutet in Sweden have managed to synthesise lung surfactant, a drug used in the care of preterm babies, by mimicking the production of spide...

Boehringer Ingelheim builds Digital Lab "BI X…

With the founding of BI X as independent subsidiary Boehringer Ingelheim will focus on breakthrough innovative digital solutions in healthcare from idea to pilot. The sta...

Bacteria used as factories to produce cancer drugs

Researchers at the Novo Nordisk Foundation Center for Biosustainability in Denmark have developed a method of producing P450 enzymes - used by plants to defend against pr...

Bristol-Myers Squibb announces new collaboration t…

Bristol-Myers Squibb Company (NYSE:BMY) announced today it has entered into a clinical research collaboration with Novartis to investigate the safety, tolerability and ef...

Clinical trial shows experimental drug's ability t…

By adding an experimental drug to a standard chemotherapy regimen, a subset of patients with metastatic pancreatic cancer had a significantly longer period before the can...

Take a coffee or tea break to protect your liver

Chronic liver diseases rank as the 12th cause of death worldwide and many of these disorders are associated with unhealthy lifestyles. Conversely, a healthier lifestyle c...

Internet withdrawal increases heart rate and blood…

Scientists and clinicians from Swansea and Milan have found that some people who use the internet a lot experience significant physiological changes such as increased hea...

Novartis presents data demonstrating efficacy of A…

Novartis today announced that it will present 19 scientific abstracts at the 59th Annual Scientific Meeting of the American Headache Society (June 8-11, 2017, Boston, USA...

AstraZeneca enters agreement with Grünenthal to di…

AstraZeneca has entered an agreement with Grünenthal for the global rights to Zomig (zolmitriptan) outside Japan. Zomig is indicated for the acute treatment of migraines ...

Pfizer and Lilly receive FDA Fast Track designatio…

Pfizer Inc. (NYSE:PFE) and Eli Lilly and Company (NYSE:LLY) today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for tanezu...

Anyone can become more curious. Is that true?

Merck, a leading science and technology company, today announced the start of an experiment entitled "Anyone can become more curious". Driven by the company’s curiosity i...

Isolated Greek villages reveal genetic secrets tha…

A genetic variant that protects the heart against cardiovascular disease has been discovered by researchers at the Wellcome Trust Sanger Institute and their collaborators...

Pharmaceutical Companies

[ A | B | C | D | E | F | G | H | I | J | K | L | M | N | O | P | Q | R | S | T | U | V | W | X | Z ]