Sodium oxybate

is GHB. It's currently being used for excessive daytime sleepiness and cataplexy. Now, it may be approved for fibromyalgia, according to DIA:

Sodium oxybate may reduce pain in patients with fibromyalgia, study suggests.

Bloomberg News (11/21, Pollack) reports, "Jazz Pharmaceuticals Inc. and UCB SA said their treatment for fibromyalgia," sodium oxybate "reduced patients' pain and fatigue in an advanced study." In the study of 548 patients," researchers found that "sodium oxybate, helped patients achieve a 30 percent reduction in pain compared with a placebo." Jazz will "ask by the end of 2009 that the U.S. Food and Drug Administration clear the therapy for sale. UCB anticipates requesting European Union clearance later."

Brad Evans

Viagra #2

Pfizer wanted to make it over-the-counter, but abandoned this idea, according to DIA:

Pfizer abandons bid to make 50-milligram Viagra available OTC in Europe.

The AP (11/20) reported, "Pfizer Inc. said Thursday it has withdrawn an application to make 50-milligram Viagra (sildenafil citrate) tablets available over the counter in Europe."

According to Bloomberg News (11/21, von Schaper), Pfizer "pulled its application with European regulators to sell a 50-milligram dose to consumers for over-the-counter use, the European Medicines Agency's (EMEA) Committee for Medicinal Products for Human Use said in a statement." The company "has been authorized to sell the prescription drug in the European Union since 1998 in 25-milligram, 50-milligram, and 100- milligram doses."

BBC News (11/20) reported that "the EMEA's Committee for Medicinal Products for Human Use (CHMP), had major concerns over making Viagra available over-the-counter." According to a CHMP spokeswoman, if Viagra "is available without prescription, there is no medical supervision which could delay diagnosis of underlying disease. The CHMP was particularly worried about the diagnosis of overt and silent cardiovascular disease, of which [erectile dysfunction] can be an early marker." She added that "a switch to being an over-the-counter medicine could lead to an increase in people who are not intended users taking Viagra recreationally."

The Financial Times (11/20, Jack) added that "the decision is a setback to Pfizer's efforts to boost sales in the increasingly competitive market for erectile dysfunction drugs ahead of the expiry of its patent in 2013, in the face of growing sales from two patented alternatives as well as many unregulated suppliers of counterfeits." If the company's application to the EMEA "had been approved, it would have only been the second [European Union]-wide approved switch of a prescription drug to non-prescription use. Alli (orlistat), GlaxoSmithKline's weight-loss medicine, was approved" in October. The Times noted that "the drug's growth had been restricted because many governments' national health services and health insurance funds failed to reimburse patients prescribed it." The U.K.'s Press Association (11/20) and AFP (11/20) also covered the story.

Brad Evans

Viagra

is now being used to improve athletic performance:

Researchers investigating whether Viagra may give athletes an unfair advantage.

In a front-page story, the New York Times (11/23, A1, Longman) reported that a study being conducted at Marywood University and financed by the World Anti-Doping Agency is investigating whether Viagra (sildenafil citrate) creates "an unfair competitive advantage in dilating an athlete's blood vessels and unduly increasing oxygen-carrying capacity." Earlier studies have found that the drug may enhance physical performance. A study "published in 2006 in The Journal of Applied Physiology" found "that some participants taking Viagra improved their performances by nearly 40 percent in 10-kilometer cycling time trials conducted at a simulated altitude of 12,700 feet -- a height far above general elite athletic competition." In addition, "a 2004 German study of climbers at 17,200 feet at a Mount Everest base camp, published in The Annals of Internal Medicine, found that Viagra relieved constriction of blood vessels in the lungs and increased maximum exercise capacity." from DIA

Brad Evans

Tetrabenazine approved for Huntington's

Tetrabenazine, available for decades in Europe, has been approved by the FDA for treatment of Huntington's disease. Tetrabenazine is symptomatic treatment of the chorea; it is not expected to alter the disease course.

Brad Evans

Arsenic poisoning and l'affaire Lafarge

The story of Marie and Charles Lafarge. Did she kill him by poisoning him with arsenic?

Brad Evans

Razadyne (galantamine)

Razadyne (galantamine) may be out as a generic soon. My question is: does this mean that prices for other medicines in the same category will decrease?

Brad Evans

Cialis: I think I don't remember...

Some men, after taking Cialis, develop transient global amnesia.

Brad Evans

Tysabri and PML

Tysabri is a monoclonal antibody used to prevent attacks in patients with multiple sclerosis. It binds to white blood cells and prevents them from entering the nervous system. For MS, it seems to a strong medicine, as strong or perhaps stronger than other available immune modulating agents. The concern is that, by preventing white cells from entering the nervous system, Tysabri might predispose to certain rare brain infections, such as progressive multifocal leukoencephalopathy (PML).

That fear was stoked by the findings in studies that, of patients who received Tysabri and other immune suppressing agents, the risk of PML was about 1/1000 for the 1st two years of treatment. Now, there is a report that two patients receiving Tysabri alone developed PML, a risk of about 1/10000 in the 1st year of taking the drug.

Brad Evans

Azilect slows Parkinson's disease?

The pharmaceutical companies Teva and Lundbeck are reporting that the "ADAGIO" study shows that rasagiline (Azilect) slows Parkinson's disease. The study used a "delayed start" methodology which is a fairly new study design. So far, I've not seen their data. The questions will be: does it really slow Parkinson's? if so, by how much?

Rasagiline improves Parkinson symptoms by inhibiting the breakdown of dopamine by the enzyme MAO-B. A major concern is that rasagiline might also inhibit MAO-A and thereby predispose patients to the MAO syndrome. This means that there may be significant drug interactions with the drug. So far, fluoxetine (Prozac), propoxyphene (Darvon and others), the quinolone antibiotic Cipro, tramadol (Ultram), methadone, and Demerol look to be the worst medicines to use in combination with rasagiline.

The concern about drug interactions is made more serious because patients may get admitted to hospital and inadvertantly be administered an interacting medicine, which would produce the MAO syndrome that could lead to death.

Brad Evans