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(Reuters)

Biotech’s Wonder Drug for Overdose Victims

By Health Care FOXBusiness

The U.S. is experiencing a spate of opiate overdose deaths from heroin as well as prescription pain medications such as Vicodin and OxyContin. In some states death rates are reportedly exceeding that of motor vehicle crashes, homicides, and other causes of young adult deaths.

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The Centers for Disease Control (CDC) reported 8,257 people in the U.S. died of heroin-related deaths in 2013, a 39% jump from the prior year.

However, the drug Naloxone, also known as Narcan, is becoming more instrumental in keeping people alive following overdose. First approved by the Food and Drug Administration in 1971 it has been proven to reverse the respiratory depression that is the fatal factor in overdoses.

“The use of Narcan is a lifesaver, it is not a solution, but a band aid, a very important band aid,” Becky Carlson, Executive Director of the Center for Prevention and Counseling in Newton NJ said.

New Jersey is among the states seeing a sharp rise in deaths related to overdoses, according to the Drug Policy Alliance. Massachusetts is also seeing a spike with over 1,200 deaths in 2014 according to reports.

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Biotech companies are recognizing the growing need to make naloxone more readily available to the public.

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Amphastar (AMPH), a small-cap biotech company, offers the Naloxone HCl Injection which is used for the complete or partial reversal of narcotic depression and is provided in pre-filled syringes for quick administration.

“Amphastar has an advantage over its competitors, as its product is the only FDA-approved pre-filled syringe, which when combined with a nozzle, saves a tremendous amount of time,” David Maris, an analyst at BMO said.

Hospira (HSP) sells an injectable formulation to administer naloxone; and Mylan Pharmaceuticals’ (MYL) product may be administered the same way as Amphastars’.

Total overall sales for the naloxone market in the U.S. as reported by IMS Health was $60.2 million in 2014, up from $34.9 million in 2013.

There is also debate over the best way to administer the drug to the victim.

Many think that while the intranasal option for delivering naloxone is not necessarily more effective than traditional injection methods, it is easier to deliver and often works as well.

Maris believes Amphastar could be the first company to get FDA approval for intranasal delivery of naloxone and that will save the company money on distribution.

“There is no published data on the effectiveness of intranasal naloxone in a real world setting, but it is reportedly 95% effective,” says Maris.

He believes that worries about the drug being administered by someone other than the police or paramedics are overblown, “solve the proximity issue, get the drug in more people’s hands, he says. “Expanded use in a responsible way could lead to fewer deaths."

Carlson notes that Narcan is available in her county if you go through training.“I think we need to be careful, and properly trained, but if it's going to save a life, it’s going to save a life.

Prices for the drug have also been rising.

Jason Shandell, President at Amphastar said: “Our price for naloxone after the increase is still the lowest among similar products in the United States. The fact that we have the lowest naloxone price is all the more remarkable because it is sold in a pre-filled syringe associated with a higher manufacturing cost.”

He added that on average, "The price of naloxone in the U.S. market (in vial form) is $37.23 per milligram, or 226% of the price of Amphastar’s.”

All in all, naloxone is an indispensable drug that saves lives and will continue to do so. Regardless of the increase in price, the drug works, and as technology improves, additional lives will undoubtedly be saved.

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