Titan Pharmaceuticals Receives Complete Response Letter from the FDA for Probuphine New Drug Application

May 13, 2013 by Leave a Comment

FDAOn April 30 Titan Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) to its New    Drug Application (NDA) for Probuphine®, the company’s investigational subdermal implant for the maintenance treatment of opioid dependence in adult patients.

The CRL states that the FDA cannot approve the application in its present form. The FDA has requested additional data supporting the efficacy of Probuphine, including:

  • The ability of Probuphine to provide opioid blockade of relevant doses of agonist
  • The effect of higher doses of Probuphine, ideally doses more closely approximating the blood plasma levels associated with sublingual doses of buprenorphine of 12 to 16 mg / day
  • Human factors testing of the training associated with Probuphine’s insertion and removal.

http://www.titanpharm.com/press/2013/13-04-30-Titan-CRL.htm

Source: Titan Pharmaceuticals – April 30, 2013

Filed Under: 2013-05-14, Buprenorphine, Medication-Assisted Treatment (MAT), News Updates, Opioid Abuse/Addiction Tagged With: ,

Vivitrol: A Shot in the Dark

May 13, 2013 by Leave a Comment

The Fix evaluates Vivitrol, the newest anti-addiction drug—actually an injectable form of an old pill. It’s definitely better than nothing. But is it $1,100 a month better?

 http://www.thefix.com/content/vivitrol-naltrexone-addiction-craving8033?page=all

Source: The Fix.com – April 30, 2013

Filed Under: 2013-05-14, Medication-Assisted Treatment (MAT), News Updates, Opioid Abuse/Addiction Tagged With: ,

No Generic Version of Painkiller Oxycontin, U.S. Health Regulators Say

May 13, 2013 by Leave a Comment

“U.S. health regulators announced that they will not approve any generic versions of the original form of the pain medication OxyContin, which was widely abused because it could be crushed and then snorted or injected to produce a quick high.

At the same time, the Food and Drug Administration also approved new labeling for a reformulated OxyContin, which was introduced by privately held manufacturer Purdue Pharma L.P. in 2010. The label will indicate that the tablets’ physical and chemical properties make them more difficult to crush, meaning that abuse is less likely than with the original.”

http://www.reuters.com/article/2013/04/16/us-oxycontin-label-idUSBRE93F1F920130416

Source: Reuters.com – April 16, 2013

Filed Under: 2013-05-14, Addiction, News Updates, Opioid Abuse/Addiction, Prescription Drugs Tagged With: ,

Neonatal Abstinence Syndrome Linked to Exorbitant Costs

May 13, 2013 by Leave a Comment

baby“A single hospital’s costs to treat neonatal abstinence syndrome in infants born to opioid-dependent mothers who received opioid replacement therapy during pregnancy totaled more than $4 million during a 3-year period, a new study shows.

The average length of stay for infants in the study ranged from 15.1 days in year 2 to 16.2 days in year 3, Dr. Roussos-Ross reported. The average total charge per infant and per hospitalization ranged from $19,535 in year 2 to $28,592 in year 3. Hospital costs per year for treating these neonates were $1.1 million in the first year, nearly $1.5 million in the second, and $1.8 million in the third year, according to the data presented.”

http://www.medscape.com/viewarticle/803656

Source: Medscape.com – May 6, 2013

Filed Under: 2013-05-14, Addiction, Medication-Assisted Treatment (MAT), Methadone, News Updates, Opioid Abuse/Addiction, Opioid Treatment Programs (OTPs) Tagged With: , , , , ,

Genes Found That May Protect Infants Born to Addicted Mothers

May 13, 2013 by Leave a Comment

“Genes tied to addiction in adults may help guide doctors to better treatments for infants born withdrawing from narcotics, according to researchers who identified the genetic link.

Babies exposed in the womb to opioid drugs who have certain variations to two genes had less severe withdrawal symptoms than those without the variants, according to a study in the Journal of the American Medical Association. The babies left the hospital sooner and needed fewer treatments, researchers said. The study, the first to look at the link between genetics and opioid withdrawal in infants, may help researchers find more effective way to treat these babies, said Jonathan Davis, senior study author and chief of newborn medicine at Floating Hospital for Children at Tufts Medical Center in Boston.”

http://www.businessweek.com/news/2013-04-30/genes-found-that-may-protect-infants-born-to-addicted-mothers

Source: BusinessWeek.com – April 30, 2013

Filed Under: 2013-05-14, Addiction, News Updates, Opioid Abuse/Addiction, Research/Surveys Tagged With: , , ,

Vaccine Halts Heroin Addiction in Rats

May 13, 2013 by Leave a Comment

Needle1“A vaccine to treat heroin addiction has proven effective in keeping drug-addicted rats from relapsing in a preclinical trial, according to a study published this week in Proceedings of the National Academy of Sciences. Researchers from the Scripps Research Institute in California say the vaccine is now ready for human trials.

Initial research into the vaccine in 2011 found that it could effectively keep rats from becoming addicted to heroin without affecting the pain relief they experienced from other opiates. This study built on those results using rats that were already addicted, finding that the vaccine could keep them from resuming compulsive drug-taking behavior even after they experienced withdrawal.”

http://www.popsci.com/science/article/2013-05/vaccine-halts-heroin-addiction-rats

Source: PopSci.com – May 7, 2013

Filed Under: 2013-05-14, Addiction, Heroin, News Updates, Opioid Abuse/Addiction Tagged With: ,

Legal Interventions to Reduce Overdose Mortality: Naloxone Access and Overdose Good Samaritan Laws

May 13, 2013 by Leave a Comment

“Opioid overdose is typically reversible through the timely administration of the drug naloxone and the provision of emergency care. However, access to naloxone and other emergency treatment is often limited by laws and that pre-date the overdose epidemic. In an attempt to reverse this unprecedented increase in preventable overdose deaths, a number of states have recently amended those laws to increase access to emergency care and treatment for opiate overdose.”

The Network for Public Health Law has published an update on access to naloxone by state and Good Samaritan laws.

http://www.networkforphl.org/_asset/qz5pvn/network-naloxone-10-4.pdf

Source: Network for Public Health Law – May, 2013

Filed Under: 2013-05-14, Addiction, News Updates, Opioid Abuse/Addiction Tagged With: , , ,

Health Law Could Overwhelm Addiction Services

May 13, 2013 by Leave a Comment

“Under healthcare reform, millions of people will become eligible for insurance coverage starting in January. The number of people seeking addiction treatment could double the article notes.

The federal government is urging states to expand their Medicaid programs. If 20 states do so, an additional 3.8 million patients with addiction problems would receive insurance, the AP notes. If almost all of the states expanded their Medicaid program, that number could reach 5.5 million. The law also designates addiction treatment as an “essential health benefit” for most commercial health plans.”

http://www.drugfree.org/join-together/addiction/millions-of-new-patients-could-receive-addiction-treatment-under-health-law?utm_source=Join%20Together%20Daily&utm_campaign=d8c82ea816-JT_Daily_News_FDA_Will_Not_Approve&utm_medium=email

Source: JoinTogether.org – April 17, 2013

Filed Under: 2013-05-14, Addiction, Healthcare Reform, News Updates, Opioid Abuse/Addiction Tagged With: , ,

2013 National Drug Control Strategy Released

May 13, 2013 by Leave a Comment

White HouseThe White House Office of National Drug Control Policy (ONDCP) released the 2013 National Drug Control Strategy on April 24. Highlights of the Strategy include:

Make Access to Treatment a Reality for Millions of Americans

  • Details actions to implement the Affordable Care Act, which – for the first time in history – ends discrimination against people with substance use disorders by requiring insurance companies to cover treatment for substance use disorders as they would for any other chronic disease;
  • Work to expand treatment and reentry services for those incarcerated; and
  • Target expansion of care for populations with an unmet need for substance abuse treatment, including veterans, college and university students, and Native Americans.

Give a Voice to Americans in Recovery

  • Work to lift the stigma associated with addiction by partnering with the recovery community to speak out about their successes and encourage others to seek treatment; and
  • Review and reform laws and regulations that unfairly target those with substance use disorders and impede recovery from addiction, including those laws and regulations that restrict access to housing, employment, and attaining a driver’s license or student loan.

The news release highlighting the new strategy is available at: http://www.whitehouse.gov/ondcp/news-releases/2013-national-drug-policy-strategy-release

A fact sheet on the new strategy is available at: https://dl.dropboxusercontent.com/u/2876748/ireta/National%20Drug%20Control%20Strategy%20Fact%20Sheet.pdf

The full 2013 National Drug Control Strategy is at: http://www.whitehouse.gov//sites/default/files/ondcp/policy-and-research/ndcs_2013.pdf

Source: WhiteHouse.gov – April 24, 2013

Filed Under: 2013-05-14, Addiction, Heroin, News Updates, Opioid Abuse/Addiction, Other Drugs of Abuse, Prescription Drugs Tagged With: , ,

National Rx Drug Abuse Summit Focused National Attention, Efforts on Addressing Prescription Drug Abuse Issues

May 6, 2013 by Leave a Comment

ROUND PILLSThis article provides an excellent recap of the second National Rx Drug Abuse Summit held April 2-4, 2013, in Orlando, Florida. Nearly 900 people from 49 states and two other countries attended the conference.

“A national outcry about the human cost of prescription drug abuse is needed if efforts to stop this national epidemic are to be successful. People of great passion and perspective are here wanting to make an impact in their communities,” said Congressman Harold “Hal” Rogers (KY-5th), chair of the U.S. House Committee on Appropriations, whose efforts to address prescription drug abuse have been recognized nationally.

“The first step is we have to admit there is a problem,” said Rogers, co-founder and co-chair of the Congressional Caucus on Prescription Drug Abuse. “I don’t think the country is there yet. We’ve got to face up to it. We’ve got to make this known … and that we’re not going to hide from it.”

http://www.workerscompensation.com/compnewsnetwork/news/16481-national-rx-drug-abuse-summit-focused-national-attention-efforts-on-addressing-prescription-drug-abuse-issues.html

Source: WorkersCompensation.com – April 12, 2013

Filed Under: 2013-05-08, Addiction, News Updates, Opioid Abuse/Addiction, Prescription Drugs Tagged With: , ,

Blog: The State of Denial (Tennessee) gets Another Chance/Update on the State of Denial: Is the Tide Finally Turning?

May 6, 2013 by Leave a Comment

“A new opioid treatment program has applied for a certificate of need with Tennessee’s Department of Mental Health and Substance Abuse Services, asking for permission to locate a methadone clinic in Eastern Tennessee. Sources say this is the eleventh attempt to locate an opioid treatment program that prescribes methadone in that part of Tennessee. In 2002, approval was given but then withdrawn due to a technicality.

Even if the certificate of need is approved, this company faces stiff opposition from the modern-day equivalent of villagers with pitchforks, demanding that no treatment center be located near them. This is the ugly face of modern day NIMBYism, and it violates the American with Disabilities Act, a topic of a past blog. (See November 14, 2012) It’s illegal, and past federal court rulings have sent a clear message to towns that violated the ADA in this way, with high six-figure fines.”

http://janaburson.wordpress.com/2013/04/07/the-state-of-denial-tennessee-gets-another-chance/

Source: Jana Burson – April 7, 2013

 Blog: Update on the State of Denial: Is the Tide Finally Turning?

“After my last post, I heard from Steve Kester, the co-owner and manager of the company seeking to open an opioid treatment program in Johnson City, Tennessee. He’s had great news: the certificate of need was approved. In addition, he was invited to write a Sunday editorial in the Johnson City Press, correcting mistaken information and explaining more about how an opioid treatment program works. It’s a great article.

Granted, it’s still posted in the paper as an opinion piece, though every bit of data he describes is science, proven in multiple studies. That’s much more than an opinion. But still, it’s progress for the paper to print this side of the treatment issue.”

Correction from the author, “I misread news about the certificate of need submitted to the state of Tennessee for an opioid treatment program in Johnson City. The certificate of need has been accepted, meaning it is complete. It has not been approved, as I said in this blog entry.”

http://janaburson.wordpress.com/2013/04/11/update-on-the-state-of-denial-is-the-tide-finally-turning/

Source: Jana Burson – April 11, 2013

Filed Under: 2013-05-08, Blog, Medication-Assisted Treatment (MAT), Methadone, News Updates, Opioid Abuse/Addiction, Opioid Treatment Programs (OTPs) Tagged With: ,

Bangor Committee Backs Methadone Bill That Would ‘Decentralize’

May 6, 2013 by Leave a Comment

Maine flag“The city’s Government Operations Committee unanimously backed a bill that would allow health care facilities to administer methadone treatments, leading to reduced costs for the state and relieving the city of a portion of its hefty share of methadone patients.

The proposal, titled An Act to Reduce Costs and Increase Access to Methadone Treatment, would allow the Department of Health and Human Services to license federally qualified health centers, health care providers or medical practices as methadone treatment clinics. It is being pitched as a cost-saving measure that will allow Mainers fighting their addictions to receive treatment closer to home.”

http://bangordailynews.com/2013/04/01/news/bangor/bangor-committee-backs-methadone-bill-that-would-decentralize-treatment-reduce-citys-share-of-patients/

Source: BangorDailyNews.com – April 1, 2013

Filed Under: 2013-05-08, Healthcare Reform, Medication-Assisted Treatment (MAT), Methadone, News Updates, Opioid Abuse/Addiction, Opioid Treatment Programs (OTPs) Tagged With: ,

Deaths Tied to Painkillers Rising in the U.S.

May 6, 2013 by Leave a Comment

hospital sign“Despite efforts by law enforcement and public health officials to curb prescription drug abuse, drug-related deaths in the United States have continued to rise, the latest data show. Figures from the U.S. Centers for Disease Control and Prevention reveal that drug fatalities increased 3% in 2010, the most recent year for which complete data are available. Preliminary data for 2011 indicate the trend has continued.

The figures reflect all drug deaths, but the increase was propelled largely by prescription painkillers such as OxyContin andVicodin, according to just-released analyses by CDC researchers.

The numbers were a disappointment for public health officials, who had expressed hope that educational and enforcement programs would stem the rise in fatal overdoses. “While most things are getting better in the health world, this isn’t,” CDC director Tom Frieden said in an interview. “It’s a big problem, and it’s getting worse.”

http://www.latimes.com/news/local/la-me-0330-rx-deaths-20130330,0,1604889.story

Source: LATimes.com – March 29, 2013

Filed Under: 2013-05-08, News Updates, Opioid Abuse/Addiction, Prescription Drugs Tagged With: ,

New Poll Ranks Chronic Pain Well Below Drug Addiction As A Major Health Problem

May 6, 2013 by Leave a Comment

“A new national public opinion poll commissioned by Research!America shows only 18% of respondents believe chronic pain is a major health problem, even though a majority of Americans (63%) say they know someone who experienced pain so severe that they sought prescription medicines to treat it. Chronic pain conditions affect about 100 million U.S. adults at a cost of approximately $600 billion annually in direct medical treatment costs and lost productivity.

Most Americans are concerned about the misuse of pain medication to treat chronic pain. A high percentage (82%) believes that taking prescription painkillers for long-term, chronic pain could result in addiction, which nearly 50% of Americans describe as a major health problem. An overwhelming majority (85%) are very concerned or somewhat concerned that prescription pain medication can be abused or misused. Indeed, 40% believe that prescription medication abuse and addiction is a major problem in their community.”

http://www.medicalnewstoday.com/releases/258897.php

Source: MedicalNewsToday.com – April 12, 2013

Filed Under: 2013-05-08, Addiction, News Updates, Opioid Abuse/Addiction, Research/Surveys Tagged With: , ,

Good Samaritan Overdose Response Laws: Lessons Learned from Washington State

May 6, 2013 by Leave a Comment

“In summary, Washington’s Good Samaritan overdose law has coincided with a great deal of progress on overdose education efforts throughout the state without any major negative consequences. We have found that collaboration among diverse stakeholders is critical to spreading the word about overdose prevention and response.  The Good Samaritan law in Washington was an important catalyst for this progress, and we encourage other states to involve public health, law enforcement, medical and treatment professionals, and advocacy organizations in spreading the word about the need for overdose education and the protections provided by Good Samaritan overdose laws.  Other states also may wish to consider cost-neutral ways of explicitly identifying an agency or standing work group to convene a multi-agency task force to help implement overdose-related laws in their legislation.”

http://www.whitehouse.gov/blog/2013/03/29/good-samaritan-overdose-response-laws-lessons-learned-washington-state

Source: WhiteHouse.gov – March 29, 2013

Filed Under: 2013-05-08, News Updates, Opioid Abuse/Addiction, Prescription Drugs Tagged With: , , ,
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