McMan's Depression and Bipolar Weekly 

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Excerpts from August 15, 2001 Vol 3 No 32 Issue

DRUG WARS 

Three articles in Psychiatric News report on a high stakes marketing war among makers of atypical antipsychotics. Worldwide sales in antipsychotics totaled more than $4 billion in 2000, according to PhRMA. Eli Lilly's Zyprexa is the world leader, with more than 6 million prescriptions written since its introduction in 1996. Pfizer recently received approval to market its next generation atypical Geodon after convincing the FDA that the weight loss benefit outweighed potential cardiac risks. The company is hoping to reach one billion in annual sales in two to three years. In a campaign aimed at Geodon, Lilly has run ads alluding to the drug's heart risks. Pfizer fired back, releasing a study showing that Zyprexa causes weight gain, plus increases cholesterol and insulin levels. Meanwhile, Janssen with its number two Risperdal ran ads about the dangers of hyperglycemia and type-2 diabetes with the use of other (unnamed) atypicals. 

Two new market players include Bristol-Myers Squibb in partnership with Otsuka, with their next generation aripiprazole in phase III clinical trials, to be marketed as Abilitat, while Novartis is developing iloperidone, in phase III trials, to be marketed as Zomaril. 

IN BRIEF 

The following studies come from the annual meeting of the International Society of Psychoneuroendocrinology last week in Quebec City, reported in Doctor's Guide: 

A University of Toronto study of 38 women has found that half of those on Depakote reported menstrual abnormalities vs 15 percent among lithium users. Those taking Depakote had higher levels of male sex hormones, with half the overweight women with menstrual abnormalities having hyperandrogenism. 

More on the high stakes war for the atypical antipsychotics market: Eli Lilly, maker of Zyprexa, has issued findings that show Risperdal (manufactured by Janssen) and the older antipsychotics increase prolactin levels in women (65.6 percent, 100 percent, and 45.1 percent for pre, peri, and postmenopausal women respectively). According to the study, as prolactin levels go higher, premenopausal women may experience cessation of their menses. Men are also affected (42.3 percent), with increased prolactin levels resulting in a reduction in their testosterone levels. 

The CRH-1 receptor antagonist, R121919, may no longer be available for human testing, but similar compounds are in the pipeline. CRH is involved in releasing the stress hormone, cortisol, into the system, which has been implicated in depression. A UK study of high dose R121919 found higher levels in liver enzymes, but a recent German study on lower doses found good results without this effect. 

A Max-Planck (Munich) study of eight individuals on 60 mgs of Remeron has found that the drug increased deep sleep while decreasing wake time and light sleep. As opposed to SSRIs and tricyclics which tend to reduce REM sleep, Remeron did not affect or slightly increased this state. 

EFFEXOR 

A study of depressed women aged 50 and older funded by Wyeth-Ayerst has found Effexor to be more effective than SSRIs or a placebo, but only in high doses. According to Vivien Burt MD, PhD of UCLA in WebMD: "One of the nice things about [Effexor] is that it is excellent for treatment of depression, [anxiety], and anxious depression. Since middle-aged and older women are more likely to experience anxious depression, particularly around the transition of menopause, it is likely to be a useful agent to try for these patients."

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