From Minyanville:

Multiple sclerosis took center stage at the 2010 American Academy of Neurology annual conference in Toronto.

One of the biggest draws at the conference was new data from Acorda Therapeutics (ACOR) concerning its recently approved drug Ampyra. The drug was approved by the FDA on January 22 and is designed to help improve walking for patients with MS.

Ampyra is a new class of drug that isn’t made to slow the progression of MS like the other drugs on the market, but is meant to treat one of its most debilitating symptoms. MS is a degenerative disease caused by the deterioration of the protective coating of nerve cells that affects 400,000 people in the United States and 2.5 million people worldwide. As the nerves around the spinal cord and in the brain become damaged, patients often lose their ability to walk, move certain parts of their body, see properly, or control their attention span, as well as other incapacitating issues.

The data presented on Ampyra at AAN included an extension of two completed phase III studies that showed patients continued to improve their average baseline walking speed over the course of the 2.5-year period. The presentation at the conference also included data from one phase II trial and two phase III trials that showed 37.3% of patients who received Ampyra showed consistent improvement in their walking ability compared to 8.9% of patients who received placebo. The Ampyra-treated patients who responded to the therapy showed an average improvement in walking speed of 25.3%.

“Specialists with whom we spoke noted that patients were coming in requesting Ampyra, and the specialists had all started to write scripts,” wrote Leerink Swann analyst Josh Schimmer concerning his time at the conference. “On average they were in the process of starting roughly 1%-2% of their patients on therapy.”

From The Washington Post:

Tackling a serious and long-standing public health problem, Deborah Autor of the Food and Drug Administration (FDA) leads an ongoing, multi-year initiative to remove hundreds of potentially dangerous prescription medicines from the market that were never approved for their safety or effectiveness as required by law.

As director of the FDA's drug compliance office, Autor designed the program to identify the unapproved drugs, evaluated the public health consequences, explored the legal challenges, set up incentive, education and outreach programs, and initiated an aggressive enforcement effort.

The FDA so far has taken enforcement actions to remove more than 500 unapproved prescription drugs from the market, impacting more than 275 drug manufacturers and distributors. Autor estimates that unapproved medicines represent less than two percent of prescriptions filled every year. But in the multibillion-dollar U.S. prescription drug market, this means that many thousands of consumers are exposed to drugs that may be unsafe.

The targeted medications have included cough medicines, antihistamines, certain single-ingredient narcotics, analgesics for pain, anti-inflammatory drugs, migraine medicines, gastrointestinal pharmaceuticals and many other products, including some prescribed to children and some reportedly linked to deaths.

Many of these unapproved medications were on the market before Congress made successive changes to the drug approval process, including 1962 amendments that required that pharmaceuticals not only be safe but also effective. While most pre-1962 prescription remedies were later evaluated by the FDA, many claimed exemptions because they or similar drugs were marketed without FDA approval before the changes to the law.

Autor's team found that most of the "grandfathered" drugs had been changed their formulations, dosages, how they are administered, and for what patients and conditions they are recommended making them "new" drugs requiring formal review and approval. Other unapproved drugs were not even grandfathered, yet manufacturers ignored the FDA approval requirement. The unapproved drugs have names and packaging that look just like approved drugs and they are even in the Physicians' Desk Reference.

For example, the FDA ordered a number of manufacturers to stop marketing unapproved drugs that contain quinine, which is often used to treat leg cramps. The agency said it has received 665 reports of serious adverse events associated with quinine use since 1969, including 93 deaths. Among the side effects of quinine are cardiac arrhythmias, thrombocytopenia and severe hypersensitivity reaction.