Alkermes Plc (NASDAQ:ALKS) Aims Sep Time Frame To File For FDA Approval To Sell Schizophrenia Drug


Dallas, Texas 04/29/2014 (FINANCIALSTRENDS) – Drug maker Alkermes Plc (NASDAQ:ALKS) has disclosed that it is all set to apply for U.S Food and Drug administration’s approval to initiate marketing of its test drug designed to treat schizophrenia after strong and sustained results were collected from its recently concluded clinical trials on the test drug.

Alkermes Plc (NASDAQ:ALKS) disclosed that it would be targeting the third quarter of this year to apply for the marketing approval, after data from clinical testing indicated that the test drug was able to demonstrate the reduction in the severity of schizophrenia attack symptoms markedly in its clinical trials. Since this announcement was made on 8th April, the share price of the drug maker has gone up by 10.5 percent in the stock market.

The drug which is to be administered to the patient in an injection format is designed to meet dosage requirements on a monthly basis. Explaining the key differentiators between their product and other competitive offerings, lkermes Plc (NASDAQ:ALKS) Chairman, President, and CEO Richard F. Pops       has been quoted to have said that, “Data from the late-stage study supported dosing of the drug once every two months. The growing market for atypical antipsychotics for schizophrenia was worth $4.5 billion in the United States. We would launch aripiprazole lauroxil using our own sales force”.

The key differentiator of Alkermes Plc (NASDAQ:ALKS) offering is that the drug once administered into the patient would convert into a compound called aripiprazole, which in turn gets released in small doses into the blood stream, thereby saving the trouble patients would have to go through of being administered the drug more frequently.

The favourable data was collected from tests conducted on 623 patients and was able to demonstrate side effects like lack of sleep, head ache and unexplained restlessness. As per latest WHO report, close to 24 million people worldwide get diagnosed with this disease every year.

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