Lawrenceville, NJ – April 26, 2010 – Aton Pharma, Inc., a diversified specialty pharmaceutical company, today announced that it has acquired the U.S. marketing rights to LODOSYN® (carbidopa) tablets from Bristol-Myers Squibb Company (BMS). LODOSYN is indicated for use with carbidopa-levodopa or with levodopa in the treatment of the symptoms of Parkinson's disease, to permit the administration of lower doses of levodopa with reduced nausea and vomiting, more rapid dosage titration, and with a somewhat smoother medication response.
“Levodopa itself is currently the most effective drug for relieving Parkinson's disease symptoms,” explained George Plotkin, M.D., Ph. D., of the Movement Disorder Center in Tyler, TX, which treats more than 2,000 Parkinson’s patients per year. “LODOSYN plays a key role in my Parkinson’s patients for whom the dosage of levodopa is less than adequate. LODOSYN permits control of Parkinson's symptoms with much lower doses of levodopa and a resulting reduction in side effects.”
“The acquisition of LODOSYN continues our mission to improve patient outcomes and quality of life by providing medically essential therapeutics, while enabling us to enter an important market,” commented Michael G. Wells, Chief Executive Officer of Aton Pharma. “Nearly one million people in the U.S. are living with Parkinson's.”
Parkinson's disease, a chronic, neurological illness that hampers movement and coordination, involves the destruction or impairment of dopamine-producing brain cells. Dopamine is a neurotransmitter, sending information to other parts of the brain to produce smooth movements. Levodopa and carbidopa are a combination of drugs that together, help to prevent Parkinson's symptoms. The drug combination works as a dopamine regulator, by increasing dopamine and assuring it stays within the brain. Carbidopa is given with levodopa to prevent it from being converted into dopamine outside the brain, helping prevent the side-effects of nausea and vomiting that occur when too much dopamine is outside of the brain. In addition, carbidopa decreases the amount of levodopa needed. Together, the two drugs provide an increase in dopamine in the brain, which is thought to be the mechanism whereby levodopa relieves symptoms of Parkinson's disease.
LODOSYN is supplied by a 25 mg tablet in a bottle of 100 tablets. Aton Pharma, Inc. will now assume exclusive responsibility for its U.S. sales and distribution.
LODOSYN (carbidopa), an inhibitor of aromatic amino acid decarboxylation, is indicated for use with carbidopa-levodopa or with levodopa in the treatment of the symptoms of idiopathic Parkinson's disease (paralysis agitans), postencephalitic parkinsonism, and symptomatic parkinsonism. LODOSYN is for use with carbidopa-levodopa in patients for whom the dosage of carbidopa-levodopa provides less than adequate daily dosage (usually 70 mg daily) of carbidopa.
LODOSYN is for use with levodopa in the occasional patient whose dosage requirement of carbidopa and levodopa necessitates separate titration of each entity. LODOSYN is used with carbidopa-levodopa or with levodopa to permit the administration of lower doses of levodopa with reduced nausea and vomiting, more rapid dosage titration, and with a somewhat smoother response. However, patients with markedly irregular ("on-off") responses to levodopa have not been shown to benefit from the addition of carbidopa.
Although the administration of LODOSYN permits control of parkinsonism and Parkinson's disease with much lower doses of levodopa, there is no conclusive evidence at present that this is beneficial other than in reducing nausea and vomiting, permitting more rapid titration, and providing a somewhat smoother response to levodopa.
Certain patients who responded poorly to levodopa alone have improved when carbidopa and levodopa were given concurrently. This was most likely due to decreased peripheral decarboxylation of levodopa rather than to a primary effect of carbidopa on the peripheral nervous system. Carbidopa has not been shown to enhance the intrinsic efficacy of levodopa.
LODOSYN has no anti-Parkinson’s effect when administered alone. LODOSYN does not decrease adverse reactions due to central effects of levodopa.
When LODOSYN is administered concomitantly with levodopa or carbidopa-levodopa combination products, the most common adverse reactions have included dyskinesias such as choreiform, dystonic, and other involuntary movements and nausea. Other adverse reactions reported with LODOSYN when administered concomitantly with levodopa alone or carbidopa-levodopa combination products were psychotic episodes including delusions, hallucinations, and paranoid ideation, depression with or without development of suicidal tendencies, and dementia. Convulsions also have occurred; however, a causal relationship with concomitant use of LODOSYN and levodopa has not been established.
About Aton Pharma, Inc.
Aton Pharma, Inc., headquartered in Lawrenceville, NJ, is a global, diversified specialty pharmaceutical company providing essential treatments for under-treated diseases. Aton’s mission is to improve patient outcomes and quality of life worldwide by enhancing and expanding access and availability of medically essential therapeutics. Aton’s portfolio of products, with sales in over 30 countries, focuses on ophthalmic diseases and orphan conditions. For more information, see www.atonrx.com.