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Category Archives: Drug Dependency

Sunovion Pharmaceuticals Receives Six Month U.S. Pediatric Exclusivity for LUNESTA® (eszopiclone)

Posted: Published on July 27th, 2012

MARLBOROUGH, Mass.--(BUSINESS WIRE)-- Sunovion Pharmaceuticals Inc. (Sunovion) announced today that it has met the United States Food and Drug Administration (FDA) requirements for pediatric exclusivity for LUNESTA (eszopiclone), a prescription sleep medicine used in adults for the treatment of insomnia. Sunovion has now gained an additional six months of United States market exclusivity for LUNESTA, which will expire on May 31, 2014. The approval of pediatric exclusivity does not mean that LUNESTA is approved for use in pediatric patients. LUNESTA is FDA approved only for use in adults with insomnia aged 18 and older. Based on study results, Sunovion will not be seeking a pediatric indication for LUNESTA. About Lunesta Indication for LUNESTA Lunesta (eszopiclone) is a prescription sleep medicine used in adults for the treatment of a sleep problem called insomnia. Symptoms of insomnia include trouble falling asleep and waking up often during the night. IMPORTANT SAFETY INFORMATION FOR LUNESTA LUNESTA acts quickly, so take it right before bed, and only if you have 8 hours to devote to sleep. Until you know how you will react to LUNESTA, you should not drive or operate machinery. Call your healthcare professional if your insomnia worsens or is not better within … Continue reading

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'Jersey Shore's The Situation on rehab stint: 'I hit rock bottom'

Posted: Published on July 27th, 2012

Mike 'The Situation' Sorrentino has admitted that he hit rock bottom before his recent trip to rehab. The Situation emerged from his rehab stint for prescription drug and alcohol dependency in April, with his representative insisting that the star was "stronger and better than ever". In an interview with In Touch, the Jersey Shore cast member revealed that his painkiller addiction was so severe that he once considered turning down a $40,000 personal appearance. "I didn't even care... When you're dependent on a substance, it's the only thing that matters," he recalled. The Situation did make the personal appearance in Australia, but was soon confronted by his family about his drug use. "On the plane home, they said, 'Mike, you've got to handle this now'. I knew that they were right, that if I didn't fix the problem there'd be no Situation," the reality star said. He also said: "[I remember thinking] 'Am I going to be that guy that was so awesome on the Jersey Shore and then... that's it?" The Situation admitted in May that completing rehab initially seemed "impossible", but insisted that the process helped him get to "a good place". Earlier this week, it was reported … Continue reading

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Modeling of new enzymes helps develop therapies for cocaine abuse

Posted: Published on July 27th, 2012

ScienceDaily (July 26, 2012) Researchers from the University of Kentucky have designed and discovered a series of highly efficient enzymes that effectively metabolize cocaine. These high-activity cocaine-metabolizing enzymes could potentially prevent cocaine from producing physiological effects, and could aid in the treatment of drug dependency. The results of this study by Chang-Guo Zhan et al are published in the journal PLOS Computational Biology. The effectiveness of the enzymes' work was evaluated through modeling cocaine pharmacokinetics, the study of the body's action on administered external substances, such as cocaine, when the enzyme exists in the body. As there is no FDA-approved anti-cocaine medication, the medical and social consequences of cocaine abuse have made the development of anti-cocaine medication a high priority. Administration of an enzyme to enhance cocaine metabolism has been recognized as a promising treatment strategy for overdose and abuse. A remarkable feature of the enzyme-based therapeutic approach is that one enzyme molecule can degrade many thousands of drug molecules per minute. This pharmacokinetic modelling is a crucial step of enzyme-based therapy development for cocaine abuse. Furthermore, the general insights of the research should also be valuable for future development of an enzyme therapy for any addictive drug, as the … Continue reading

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The modeling of new enzymes helps develop therapies for cocaine abuse

Posted: Published on July 27th, 2012

Researchers from the University of Kentucky have designed and discovered a series of highly efficient enzymes that effectively metabolize cocaine. These high-activity cocaine-metabolizing enzymes could potentially prevent cocaine from producing physiological effects, and could aid in the treatment of drug dependency. The results of this study by Chang-Guo Zhan et al are published in the journal PLOS Computational Biology. The effectiveness of the enzymes' work was evaluated through modeling cocaine pharmacokinetics, the study of the body's action on administered external substances, such as cocaine, when the enzyme exists in the body. As there is no FDA-approved anti-cocaine medication, the medical and social consequences of cocaine abuse have made the development of anti-cocaine medication a high priority. Administration of an enzyme to enhance cocaine metabolism has been recognized as a promising treatment strategy for overdose and abuse. A remarkable feature of the enzyme-based therapeutic approach is that one enzyme molecule can degrade many thousands of drug molecules per minute. This pharmacokinetic modelling is a crucial step of enzyme-based therapy development for cocaine abuse. Furthermore, the general insights of the research should also be valuable for future development of an enzyme therapy for any addictive drug, as the general methodology of the … Continue reading

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Ask the GAL: Readers respond on how to help children in dependency

Posted: Published on July 25th, 2012

Last week I asked you to respond to the question: What can we, as a community or individually, do to help children in dependency? I want to share with you some excerpts of the 60 responses I received. A: Individually I think we all have to be more vigilant and get involved when it comes to children. When we see abuse, I think it is our duty to get involved. As a society, I think the pharmaceutical companies should somehow bear the cost of taking care of some of these children born addicted to drugs. I know this is a stretch, but prescription drugs are responsible for so many problems that we, as a society, are going to have to pay for. I would love to start a class action law suit for every child in dependency because of prescription drugs. -- Robert Hupalo A: As a community, we can advocate to ensure that the medical profession, pharmacies and drug manufacturers are held accountable for any indiscriminate use of painkillers, in order to reduce criminal activity and the addictions that can lead to neglect of children. -- Donna Townsend A: Establish a local transportation service dedicated to dependent children. -- … Continue reading

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Australian drug mule gets 8 years in Bali jail

Posted: Published on July 24th, 2012

Indonesian prosecutors may appeal the sentence given to an Australian drug mule jailed for attempting to smuggle hashish and methamphetamines into Bali hidden in his stomach. Edward Myatt was jailed for eight years on Monday in a ruling that shocked prosecutors, who had demanded a sentence of 15 years. The 54-year-old Ballarat-born man was also fined 1.5 billion rupiah ($A155,000). If he fails to pay the fine, Myatt will be required to serve an additional four months in jail. The decision is another major relief for Myatt, who was indicted on three charges, including one count of trafficking, which carries a maximum penalty of death. He was stopped as he arrived at Bali's Ngurah Rai Airport in February on a flight from India after he aroused the suspicions of Customs officers. He was later found to have swallowed more than 70 plastic casings containing 1.1kg of hashish and four grams of methamphetamine, otherwise known as ice. It had been expected he would receive a similar sentence to Sydney-man Michael Sacatides, who earlier this year was given 18 years for attempting to smuggle 1.7kg of ice into Bali from Thailand. But chief judge Gunawan Tri Budiono said that while the evidence … Continue reading

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New executive takes helm of Utah County courts

Posted: Published on July 23rd, 2012

PROVO -- Shane Bahr was working in an Idaho drug court in 2007 when he suddenly had a chance to move to Colorado. "A lot of the courts that I worked in had anywhere from 10 to 40 participants," Bahr recalled last week. "Then we moved to Denver and there were 2,000." The dramatic change posed new challenges for Bahr, but he stuck with the job for five years until another one opened up, this time in Provo. In June, Bahr was selected to replace Paul Vance as the trial court executive of Utah's Fourth District Court. According to court spokeswoman Nancy Volmer, the position requires providing support to 13 judges, managing a staff of 90 people and overseeing court facilities. Bahr also will manage court security and budgets, Volmer added in an email. Utah's Fourth District covers Utah County, as well as courts in Juab, Wasatch and Millard counties. To meet those challenges that come with Bahr's new array of duties, he'll have to draw on his previous experience in Idaho and Colorado. Bahr said his career in criminal justice began 15 years ago in Rexburg, where he worked as a probation officer. That position eventually led to a … Continue reading

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Orexo Reports Positive Feedback from Pre-NDA Meeting with FDA – Clearing Path for Regulatory Submission of OX219

Posted: Published on July 23rd, 2012

UPPSALA, Sweden--(BUSINESS WIRE)--Regulatory News: It is very good news for Orexo. Our meeting with FDA was constructive and we received a general confirmation of the approaches we have taken in developing OX219 for the US market A meeting with the US regulatory agency FDA held on July 17 has confirmed that the Swedish pharmaceutical company Orexo (STO:ORX) is on track with its preparation for a regulatory submission of a new drug approval (NDA) for its medicine for treatment of opioid dependency, OX219. The meeting was a scheduled pre-NDA consultation and was undertaken to review critical regulatory issues, including adequacy of the clinical program and pre-clinical documentation, as well as the planned documentation on the product including the chemistry, manufacturing and control (CMC) plans, prior to submission of the actual documentation. The feedback Orexo appreciated was an understanding that the two pivotal clinical studies for OX219 were adequate to support a regulatory submission and that no further clinical data were required pre-approval. The agency also concurred with pre-clinical documentation compiled by Orexo and did not request further data prior to submission of the NDA. As previously communicated, Orexo is currently awaiting completion of certain technical stability data for OX219 during Q4-2012, … Continue reading

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Aussie drug mule gets 8 years in Bali jail

Posted: Published on July 23rd, 2012

An Australian man caught trying to smuggle hashish and methamphetamines into Bali hidden in his stomach has been sentenced to eight years in jail. Edward Myatt, from Ballarat in Victoria, was stopped as he arrived at Bali's Ngurah Rai Airport in February on a flight from India after he aroused the suspicions of Customs officers. He was later found to have swallowed more than 70 plastic casings containing 1.1kg of hashish and four grams of methamphetamine, otherwise known as ice. The 54-year-old drug mule had been facing the possibility of a death sentence under Indonesia's harsh narcotics laws. The Bali prosecutor's office, which indicated earlier in the trial it would push for Myatt to face a firing squad, had requested a sentence of 15 years after receiving orders from the Indonesian Attorney-General's Department in Jakarta. But a panel of judges in the Denpasar District Court on Monday instead sentenced Myatt to just eight years. He was also fined 1.5 billion rupiah ($A155,000). If he fails to pay the fine, Myatt will be required to serve an additional four months in jail. It had been expected he would receive a similar sentence to Sydney man Michael Sacatides, who earlier this year … Continue reading

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Calls for a dedicated drug abuse rehabilitation centre

Posted: Published on July 21st, 2012

Calls for a dedicated drug abuse rehabilitation centre MARANYANE NGWANAAMOTHO Staff Writer She says that at BOSASNet, they offer only outpatient services to people gripped with substance abuse and dependency because they do not have the capacity to admit patients for detoxification under the supervision of qualified psychologists and therapists. "Drug abuse is when a substance is not used for its intended purpose, which involves over indulgence while drug dependency is when the user cannot or is unable to stop using the drug on his or her own," she says. Mothibatsela is of the view that unless the fight against substance abuse and dependency is given a united approach by the private sector, non-governmental organisations, government and the public at large, the fight against drug use will be fruitless. "We all need to acknowledge there are issues concerning drug use and dependency. We need appropriate funds and resources and we need the public's buy-in to win the fight against drug use and dependency," she said to Mmegi yesterday. Mothibatsela says that the occurrence of drug use and dependency in Botswana cannot be denied, especially since they continue to receive people who admit to using both legal and illegal substances. "We … Continue reading

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