Egalet Corporation, a rapidly growing local integrated specialty pharmaceutical company, is devoted to making powerful pain medicines for patients with moderate to severe pain safer from abuse, officials said.
When Robert Radie, president and CEO, first heard about Egalet, he was immediately interested. The company began in Denmark and Radie knew some of its investors. He came aboard in 2012 after Topaz Pharmaceuticals Inc., a company of which he was also president and CEO, was acquired by Sandofi Pasteur.
"I was really intrigued with the magnitude of the problem of prescription drug misuse," Radie said. Some 100 million people are living with chronic pain. Egalet, he said, has a "unique technology" to help to stop addiction bef ore it can start.
Even patients who are not trying to abuse their medication disregard instructions and try to chew it instead of swallowing it to get more immediate pain relief, which can lead to overdoses from a too large amount, according to Radie.
Egalet offers two products, SPRIX and OXAYDO, and filed in December for FDA approval for a third, ARYMO, an abuse-deterrent formulation of extended release morphine. Other drugs are also in the works.
The company's pills are made with their propriety "Guardian Technology," which makes them too hard to pound into powders to be snorted and unable to be chewed. Also, if someone tries to turn them into an injectable liquid, the pills turn to a gummy, gooey substance instead.
"It's exciting," Radie said of the products. "Nobody's done this before."
SPRIX, is a nasal spray, a nonsteroidal anti-inflammatory and a form of ketorolac tromethamine. It is taken for strong but short-term pain relief a nd is not an opioid. It can be used either in hospitals or by patients at home. And, it can reduce the need for doctors to prescribe narcotics to manage pain.
OXAYDO (oxycodone HCl, USP), meanwhile, is the first and only approved immediate release opioid analgesic with abuse-deterrent properties, according to company officials. It's for use in management of acute and chronic pain that's moderate to severe. Continued...
Salespeople for the company are pitching these first two products that they licensed to doctors who are the top pain specialists around the country."The feedback (from physicians) has been extremely positive," said Radie. Doctors view SPRIX as "an excellent alternative to an opioid. OXAYDO is in its early days of use but also has also been well received, he said.
While the Guardian Technology can help prevent people from misusing opioid medicines and becoming addicted, Radie said, it is only "a very important piece of this complex puzzle."
Radie noted that while people often talk about the problem of misuse and addiction, they don't mention that some patients do need pain medication to go about their daily business.
"What doesn't get talked about is the pain patient who needs medicine to lead a functional life, to go to work or take care of their families" said Radie. "We can't lose sight of the fact that some people are not able to function without their medication. You hear stories about patients, not abusers, just trying to live their lives, to function, and having to go to two or three different pharmacies [because] pharmacies are not stocking opioids. It's frustrating. They get stigmatized, just trying to get out of pain. It cuts across socioeconomic lines."
However, the number one cause of accidental death in the U.S. is prescription drug use and misuse, he said. Some 46 Americans die every day from prescription opioid overdoses with 80 percent of those deaths unintended, according to the U.S. Pain Foundation.
Meanwhile, the Centers for Disease Control issued new recommendations for opioid prescription use this year, recognizing the epidemic of abuse and misuse and addiction. The most important guideline is that non-opioid therapy is the preferred treatment for chronic pain and "opioids should be used only when benefits for pain and function are expected to outweigh risks."
Doctors are u nder constraints to monitor their patients who receive opioids, using the lowest effective dosage.
One side effect of opioid addiction is that some patients who are no longer able to get prescriptions from their doctors turn to heroin. Drug deaths from heroin nearly quadrupled from 2000 to 2013, according to the CDC, going from 0.7 deaths per 100,000 people to 2.7 deaths per 100,000 in that time period. Heroin deaths have been increasing in all regions of the country, but the Midwest has been the hardest hit.
Drug overdose is the number one cause of injury related death in the U.S., with 43,982 dying in 2013, the CDC stated. With such a widespread problem, other pharmaceutical companies are also offering versions of abuse-deterrent opioid medications. Continued...
Law enforcement officials are well aware of these problems and the impact on society, said Radnor Police Lt. Andy Block."It's an ongoing issue with people becoming addicted to painkillers," said Block.
"They're injured. They go to a doctor. They're prescribed some type of prescription for pain management. It's usually opioid based. It's not their intention to become addicted, but they do."
The person who becomes addicted to opioid narcotics has "a daily need for it."
Some real estate agents report that people pretending to be prospective buyers will go through medicine closets to steal opioid medications, said Block.
"In the region it's been happening, people report pain medicine missing," he said.
Also, the thieves might not be stealing it for themselves but to resell it. Oxycodone pills can go for $30, $50, or $60 a pill on the street, he said.
"Ultimately, what happens is it becomes cost prohibitive so they turn to heroin, also opioid-based," said Block. The Philadelphia area is one of the hubs for the heroin epidemic on the East Coast, along with Baltimore, he said. Traffickers are bringing heroin up from Mexico, he said.
Also, area police officers have begun to carry Narcan, a drug that can reverse the effects of an overdose.
Police said another side effect is an increase in burglaries and other property crimes as addicts steal to support their habit. And, of course, heroin might be laced with other drugs or of a high purity. Continued...
"They can take one hit and overdose," said Block. "It can be fatal.""In my career, there's epidemic proportions," he said. "If you live in this area, you can jump in your car and drive to North Philadelphia and be there in 45 minutes (to buy heroin). It's very sad and very disturbing."
While some people go from prescription medications to heroin, others graduate from "gateway drugs like marijuana or alcohol [when] someone introduces them to it. People will tell you the first hit they take, it's unbelievable euphoria. Then they'll never experience a high like that again. They'll never have that again. They call it chasing the dragon," said Block. "It is so addictive you want to keep going back and get that initial high. It boggles your mind that people will do it.
"It's much more economical," Block said about heroin. "It's out here in the five-county region. We've made arrests where people came from Lancaster County and go to Philadelphia for their drugs and stopped in Radnor. Once they become addicted it's nasty. They will do anything they can to get that high. You have that vicious cycle. If they get arrested, at least they get into rehab and they have a chance to get healthy again."
When told about Egalet's products to prevent opioid misuse and addiction, Block said not getting hooked on prescription pharmaceuticals to begin with would be very helpful in combatting the problem.
Egalet, which has 80 employees, 50 in the U.S. and the rest in Denmark, moved to a larger corporate headquarters in Wayne at the end of February. Their new 19,797-square-foot office space, complete with standing desks, has a Silicon Valley, high-tech vibe, with large windows to let natural light flow through the space. Their products are manufactured by Halo Pharmaceutical in Whippany, N.J.
For more information: www.egalet.com
Tredyffrin >> With the problem of addiction to opioid-based pain medicine rampant nowadays, a part of the solution may be to produce medicines that are resistant to abuse to prevent people from becoming addicted in the first place.Egalet Corporation, a rapidly growing local integrated specialty pharmaceutical company, is devoted to making powerful pain medicines for patients with moderate to severe pain safer from abuse, officials said.
When Robert Radie, president and CEO, first heard about Egalet, he was immediately interested. The company began in Denmark and Radie knew some of its investors. He came aboard in 2012 after Topaz Pharmaceuticals Inc., a company of which he was also president and CEO, was acquired by Sandofi Pasteur.
"I was really intrigued with the magnitude of the problem of prescription drug misuse," Radie said. Some 100 million people are living with chronic pain. Egalet, he said, has a "unique technology" to help to stop addiction bef ore it can start.
Even patients who are not trying to abuse their medication disregard instructions and try to chew it instead of swallowing it to get more immediate pain relief, which can lead to overdoses from a too large amount, according to Radie.
Egalet offers two products, SPRIX and OXAYDO, and filed in December for FDA approval for a third, ARYMO, an abuse-deterrent formulation of extended release morphine. Other drugs are also in the works.
The company's pills are made with their propriety "Guardian Technology," which makes them too hard to pound into powders to be snorted and unable to be chewed. Also, if someone tries to turn them into an injectable liquid, the pills turn to a gummy, gooey substance instead.
"It's exciting," Radie said of the products. "Nobody's done this before."
SPRIX, is a nasal spray, a nonsteroidal anti-inflammatory and a form of ketorolac tromethamine. It is taken for strong but short-term pain relief a nd is not an opioid. It can be used either in hospitals or by patients at home. And, it can reduce the need for doctors to prescribe narcotics to manage pain.
OXAYDO (oxycodone HCl, USP), meanwhile, is the first and only approved immediate release opioid analgesic with abuse-deterrent properties, according to company officials. It's for use in management of acute and chronic pain that's moderate to severe.
Salespeople for the company are pitching these first two products that they licensed to doctors who are the top pain specialists around the country.
"The feedback (from physicians) has been extremely positive," said Radie. Doctors view SPRIX as "an excellent alternative to an opioid. OXAYDO is in its early days of use but also has also been well received, he said.
While the Guardian Technology can help prevent people from misusing opioid medicines and becoming addicted, Radie said, it is only "a very important piece of this complex puzzle."
Radie noted that while people often talk about the problem of misuse and addiction, they don't mention that some patients do need pain medication to go about their daily business.
"What doesn't get talked about is the pain patient who needs medicine to lead a functional life, to go to work or take care of their families" said Radie. "We can't lose sight of the fact that some people are not able to function without their medication. You hear stories about patients, not abusers, just trying to live their lives, to function, and having to go to two or three different pharmacies [because] pharmacies are not stocking opioids. It's frustrating. They get stigmatized, just trying to get out of pain. It cuts across socioeconomic lines."
However, the number one cause of accidental death in the U.S. is prescription drug use and misuse, he said. Some 46 Americans die every day from prescription opioid overdoses with 80 percent of those deaths unintended, accordin g to the U.S. Pain Foundation.
Meanwhile, the Centers for Disease Control issued new recommendations for opioid prescription use this year, recognizing the epidemic of abuse and misuse and addiction. The most important guideline is that non-opioid therapy is the preferred treatment for chronic pain and "opioids should be used only when benefits for pain and function are expected to outweigh risks."
Doctors are under constraints to monitor their patients who receive opioids, using the lowest effective dosage.
One side effect of opioid addiction is that some patients who are no longer able to get prescriptions from their doctors turn to heroin. Drug deaths from heroin nearly quadrupled from 2000 to 2013, according to the CDC, going from 0.7 deaths per 100,000 people to 2.7 deaths per 100,000 in that time period. Heroin deaths have been increasing in all regions of the country, but the Midwest has been the hardest hit.
Drug overdose is the number one cause o f injury related death in the U.S., with 43,982 dying in 2013, the CDC stated. With such a widespread problem, other pharmaceutical companies are also offering versions of abuse-deterrent opioid medications.
Law enforcement officials are well aware of these problems and the impact on society, said Radnor Police Lt. Andy Block.
"It's an ongoing issue with people becoming addicted to painkillers," said Block.
"They're injured. They go to a doctor. They're prescribed some type of prescription for pain management. It's usually opioid based. It's not their intention to become addicted, but they do."
The person who becomes addicted to opioid narcotics has "a daily need for it."
Some real estate agents report that people pretending to be prospective buyers will go through medicine closets to steal opioid medications, said Block.
"In the region it's been happening, people report pain medicine missing," he said.
Also, the thieves might not be stealing it for themselves but to resell it. Oxycodone pills can go for $30, $50, or $60 a pill on the street, he said.
"Ultimately, what happens is it becomes cost prohibitive so they turn to heroin, also opioid-based," said Block. The Philadelphia area is one of the hubs for the heroin epidemic on the East Coast, along with Baltimore, he said. Traffickers are bringing heroin up from Mexico, he said.
Also, area police officers have begun to carry Narcan, a drug that can reverse the effects of an overdose.
Police said another side effect is an increase in burglaries and other property crimes as addicts steal to support their habit. And, of course, heroin might be laced with other drugs or of a high purity.
"They can take one hit and overdose," said Block. "It can be fatal."
"In my career, there's epidemic proportions," he said. "If you live in this area, you can jump in your car and drive to North Philadelphia an d be there in 45 minutes (to buy heroin). It's very sad and very disturbing."
While some people go from prescription medications to heroin, others graduate from "gateway drugs like marijuana or alcohol [when] someone introduces them to it. People will tell you the first hit they take, it's unbelievable euphoria. Then they'll never experience a high like that again. They'll never have that again. They call it chasing the dragon," said Block. "It is so addictive you want to keep going back and get that initial high. It boggles your mind that people will do it.
"It's much more economical," Block said about heroin. "It's out here in the five-county region. We've made arrests where people came from Lancaster County and go to Philadelphia for their drugs and stopped in Radnor. Once they become addicted it's nasty. They will do anything they can to get that high. You have that vicious cycle. If they get arrested, at least they get into rehab and th ey have a chance to get healthy again."
When told about Egalet's products to prevent opioid misuse and addiction, Block said not getting hooked on prescription pharmaceuticals to begin with would be very helpful in combatting the problem.
Egalet, which has 80 employees, 50 in the U.S. and the rest in Denmark, moved to a larger corporate headquarters in Wayne at the end of February. Their new 19,797-square-foot office space, complete with standing desks, has a Silicon Valley, high-tech vibe, with large windows to let natural light flow through the space. Their products are manufactured by Halo Pharmaceutical in Whippany, N.J.
For more information: www.egalet.com
Source: Local company produces tablets to deter opioid-abuse; two meds on market now with one awaiting FDA approval
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