2007: a year of breakthrough psychotropics?

Could 2007 be a year of new blockbuster psych meds? If these drugs pass Phase III trials, it could be.

  • SR 58611 is a beta 3-adrenoreceptor agonist being developed by the French mega-conglomerate sanofi-aventis. It will be the first in this category of antidepressants to hit the market if everything goes as planned. While SR 58611 didn’t induce any statistically significant weight loss, other drugs in the category have shown some potential in this area. A drug that makes you happy and thin: everyone’s going to be popping that like candy.
  • Neurokinin antagonists – Several drugs in this category are in development. Two that are furthest along in trials are casopitant by GlaxoSmithKline and saredutant by sanofi-aventis. Drugs in this category are thought to work by adjusting levels of Substance P, which regulates mood, anxiety, and pain among other things. There is already one drug in this category already on market (U.S. market, not Canada – Health Canada hasn’t yet approved it), namely the antiemetic Emend (aprepitant) by Merck & Co. Clinical trials on Emend failed to show it is an efficient treatment for depression, and Merck has scrapped plans to market it as such.
  • Valdoxan from Servier is a selective serotonin antagonist and selective melatonin agonist. The application for this antidepressant has been rejected by E.U. and is pending in the U.S.
  • Wyeth will almost certainly begin sales of Pristiq (desvenlafaxine), which is a metabolite of Effexor, currently the best selling antidepressant in Canada.
  • Solvay, Lundbeck, and Wyeth are set to introduce bifeprunox, a selective serotonin/dopamine partial agonist, pending approval from FDA. This will be the second drug in this category of atypical antipsychotics after Abilify from Otsuka and Bristol-Meyers Squibb.
  • AstraZeneca will introduce Seroquel SR (quetiapine), a once-a-day, sustained release version of Seroquel. Seroquel, which has been used for treatment of schizophrenia and bipolar mania, has been a no-no for severly affected patients because multiple dosings were required throughout the day to maintain a high level of quetiapine in the system around the clock.
  • Gabaxadol is a new sleep-aid being tested by Lundbeck and Merck & Co. This drug, upon approval, could be scheduled in U.S. as other GABA-A agonists such as Ambien and Lunesta are Schedule IV.
  • On the ADHD front, Shire will be introducing Connexyn (guanfacine), which was originally approved as an antihypertensive. It will be the first ADHD drug in its category and the second non-stimulant ADHD drug after Strattera (atomoxetine) from Eli Lilly.

So how long will it take until you are able to beg your doctor for a prescription for these drugs? Assuming the drug companies want to sell them in Canada (Abilify is not available in Canada because Bristol-Meyers Squibb fears once the drug goes on sale in Canada where prescription drugs are price controlled, they will no longer be able to charge an obscene $9 per tablet in the U.S.), it will take anywhere between 2 and 5 years. Drug companies usually submit an application in Canada after FDA approves it, and it takes Health Canada up to three years to review the application.

If the drug isn’t available after 5 years, what gives? This usually means:

  1. The drug company doesn’t want to sell them in Canada because it fears re-importation back to the U.S., or
  2. Health Canada rejected the application for sales.

It’s not possible to find out which is the case without a spy in the drug company because Health Canada, unlike the FDA, doesn’t tell the public what drugs they are currently reviewing for market approval and what drugs they have rejected. Health Canada only reports the number of application they are currently reviewing and what drugs they decided to approve. That is, the drug approval process in Canada is completely non-transparent.

Source: Neurotransmitter.net – Future Treatments for Depression, Anxiety, Sleep Disorders, Psychosis, and ADHD
More information on Health Canada drug approval process transparency: Transparency and the Drug Approval Process at Health Canada

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