News & Updates – May 14, 2013: Issue 183

May 14, 2013

Compiled & Edited by Sue Emerson – Publisher
Prior Edition: May 8, 2013
List of all News/Updates

MEDICATION-ASSISTED TREATMENT (MAT) AND OPIOID ABUSE/ADDICTION

GOVERNMENT

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

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

Vivitrol: A Shot in the Dark

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

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

“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

Neonatal Abstinence Syndrome Linked to Exorbitant Costs

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

Genes Found That May Protect Infants Born to Addicted Mothers

“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

Vaccine Halts Heroin Addiction in Rats

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

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

“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

Health Law Could Overwhelm Addiction Services

“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

2013 National Drug Control Strategy Released

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

Two Congressmen Talk Addiction With The Fix

In an exclusive interview, The Fix talks with the co-chairs of the Congressional Addiction, Treatment and Recovery Caucus about what the US is getting right and wrong.

It’s been said that addiction and recovery don’t get enough attention in Washington, DC—a result of the stigma attached to the disease, as well as the reluctance of some sober people to speak out about what they and their families have been through. And the latter is precisely what is needed to push forward a positive legislative agenda on addiction and recovery, according to Rep. Tim Ryan, Democrat of Ohio, who co-chairs the 62-member Congressional Addiction, Treatment and Recovery Caucus alongside Rep. John Fleming, Republican of Louisiana, who is a physician.

Questions and Answers include:

  • Do you feel there’s a bipartisan consensus on what needs to be done with addiction treatment in America?
  • I’ve heard talk of the possibility of an Americans in Recovery Act bill. If such a piece of legislation were written, what sort of provisions do you think it should contain?
  • Do you feel individuals in recovery should be more open in order to break the stigma associated with their disease?
  • Do you think there’s any stigma on Capitol Hill about being associated with addicts or people in recovery?
  • Despite what either of you may feel about the Affordable Care Act as a whole, do you in general support requiring insurance companies to cover treatment for substance use disorders?
  • Does current US drug policy—including incarceration for possession, aggressively going after drug traffickers and spending lots of money to do that—contribute positively or negatively to addiction rates and the availability and efficacy of treatment?

http://www.thefix.com/content/congressional-addiction-treatment-recovery-caucus-interview00416?page=all

Source: TheFix.com – May 3, 2013

How to Make Drug Courts Work

Pg8_law“Drug courts have made a surprisingly small contribution to the crime reduction that has occurred over the past twenty years. They process only a small fraction of drug-involved offenders within the criminal justice system, and an even smaller fraction of offenders who commit serious crimes. Most chronic cocaine, heroin and methamphetamine users who reach court will end up in jail or prison, often for minor crimes.

Drug courts could be more helpful in reducing crime and incarceration, but only if they become more ambitious and less risk-averse by taking in populations likely to serve real time.”

http://www.washingtonpost.com/blogs/wonkblog/wp/2013/04/26/how-to-make-drug-courts-work/

Source: WashingtonPost.com – April 26, 2013

News & Updates – May 8, 2013: Issue 182

May 8, 2013

Compiled & Edited by Sue Emerson – Publisher
Prior Edition: April 8, 2013
List of all News/Updates

MEDICATION-ASSISTED TREATMENT (MAT) AND OPIOID ABUSE/ADDICTION

GOVERNMENT

MISCELLANEOUS

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

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

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

“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

Site last updated May 13, 2013 @ 4:22 pm