Content about Amphetamines

FRANKFORT, Ky. — The debate on the prescription status of pseudoephedrine in the state of Kentucky heated up last week as the deputy director of the White House Office of National Drug Control Policy Benjamin Tucker on Wednesday told Kentucky lawmakers that they should mandate PSE to Rx-only status, according to reports.

Tucker last week was the keynote speaker at the Kentucky Drug Summit, part of the Kentucky League of Cities annual convention, and headlined a panel of federal, state and local experts to examine pill mills, meth labs and prescription drug abuse.

ROCKVILLE, Md. — Methamphetamine use is down by 50%, even as use of illicit drugs continued to climb between 2008 and 2010, according to a national survey conducted by the Substance Abuse and Mental Health Services Administration that was released last week.

The number of current methamphetamine users decreased from 731,000 people ages 12 years and older (0.3% of the population) in 2006  to 353,000 (0.1%) in 2010.

DUBLIN — Shire has filed patent infringement suits against two generic drug makers relating to its attention deficit hyperactivity disorder treatment.

Shire said it has filed lawsuits in the U.S. District Court for the District of New Jersey against Amneal Pharmaceuticals and Sandoz. Amneal and Sandoz recently filed abbreviated new drug applications with the Food and Drug Administration to market generic Vyvanse (lisdexamfetamine), an ADHD drug.

MADISON, Miss. — The Food and Drug Administration has approved two cough-cold medications made by Cypress Pharmaceutical, the company said Monday.

Cypress announced the approval of Zutripro (hydrocodone bitartrate, chlorpheniramine maleate and pseudoephedrine hydrochloride) and Rezira (hydrocodone bitartrate and pseudoephedrine). Both drugs are oral solutions and, because they contain the opioid hydrocodone, are classified as schedule III controlled substances by the Drug Enforcement Administration. Cypress subsidiary Hawthorn Pharmaceuticals will market the drugs.

ST. LOUIS — Missouri’s House of Representatives on Monday voted 100 in favor and 50 opposed to reclassifying pseudoephedrine as a prescription-only remedy and subsequently moved the matter to the state Senate — this despite the fact that electronic track-and-trace has been up and running for the past six months, blocking more than 30,000 potentially illegal PSE purchases, stated Scott Melville, president and CEO of the Consumer Healthcare Products Association.

TOPEKA, Kansas — Kansas on Monday officially made the move from a paper tracking system for pseudoephedrine sales to the electronic tracking capabilities afforded through the National Precursor Log Exchange, according to an Associated Press report published Monday. Kansas first announced its intent to switch over to NPLEx in March 2010.

DUBLIN — British drug maker Shire has filed suit against Watson Pharmaceuticals and subsidiaries, alleging patent infringement in a case concerning a drug used to treat attention deficit hyperactivity disorder.

Shire announced Wednesday that it had filed the suit in the U.S. District Court for the Southern District of New York against Watson and several subsidiaries over their attempt to market a generic version of Adderall XR (amphetamine, dextroamphetamine mixed salts) and breach of contract.

WHAT IT MEANS AND WHY IT’S IMPORTANT — The latest Arkansas proposition to control PSE sales may deliver the biggest blow to the over-the-counter accessibility argument, as it restricts sales to Arkansas residents who have a state-issued picture ID and who don’t look like they might be meth addicts. It also is no more fair or effective to have pharmacists decide who looks like a meth addict and who doesn't. Worse, the bill includes a provision that would allow the Arkansas Board of Pharmacy to color any OTC medicine with the same brush as PSE.

LITTLE ROCK, Ark. — The Arkansas House on Wednesday passed a bill that would restrict the behind-the-counter sale of pseudoephedrine to pharmacists only. In other words, pharmacy technicians no longer would be allowed to sell products containing PSE.

The measure by state Sen. Percy Malone passed 60-31, according to published reports.

PHILADELPHIA — Watson Labs is hoping to be the first to market a generic version of a popular drug for attention deficit hyperactivity disorder.

British drug maker Shire announced Thursday that it had received notification that Watson filed for regulatory approval of a version of Adderall XR (dextroamphetamine and amphetamine) capsules with the Food and Drug Administration. Watson’s application contained a Paragraph IV certification, a legal assertion that the patent covering Adderall XR is invalid, unenforceable or won’t be infringed by Watson’s product.

LITTLE ROCK, Ark. — Arkansas on Friday became the fourth state this year to entertain making the popular decongestant pseudoephedrine available only by prescription.

NASHVILLE, Tenn. — Tennessee makes the third state this year, joining Kentucky and Nevada, that is considering state legislation to mandate the sale of pseudoephedrine as prescription-only. That could prove a big concern for the legitimate market for PSE products on account of the potential snowball effect such legislation could have on neighboring states. According to a government review staff in Kentucky, at least 97.8% of all PSE sales are bought for legitimate use.