Recent Psychotropic Medication Arrivals: Can We Really Call Them New Drugs?

Recent Arrivals

Intuniv (guanfacine LA). Intuniv is a long-acting formulation of the alpha-2 agonist Tenex (guanfacine). Intuniv is FDA approved for the treatment of ADHD in children and adolescents ages 6-17. The drug is available in 1mg, 2mg, 3mg, and 4mg tablets, and is dosed once daily.

Guanfacine was first marketed as an antihypertensive for the control of high blood pressure. Its use then expanded to the treatment of some anxiety conditions and to control hyperactivity and impulsivity associated with ADHD. Guanfacine has also been used “off label” to help manage irritability and aggression associated with oppositional defiance, conduct disorder and temper tantrums linked to the pervasive developmental disorders (autism, Asperger’s syndrome).

Intuniv can be used alone, but probably works best in combination with the classic methylphenidate or dextroamphetamine psychostimulants. Because it lowers blood pressure and slows pulse rate, it is likely to be most effective in controlling the peripheral symptoms of ADHD – hyperactivity, impulsivity, and irritability. In my view, claims that Intuniv acts directly on the prefrontal cortex to improve focus and distractibility are pharmacologically questionable, poorly explained and merely drug company hype.

Side effects include: sleepiness, headache, sedation and possible fainting. Blood pressure and heart rate should be regularly monitored in children and adolescents taking Intuniv.

Trazodone Extended-Release. This long-acting offspring of the popular immediate-release antidepressant trazodone sports a combination rapid and sustained-release technology that claims to maintain blood levels within therapeutic range for 24 hours, thereby potentially reducing the incidence and severity of side effects while maintaining efficacy in the treatment of major depressive disorder in adults.

So what’s really new here? Nothing. Again, we’re lead to believe that with advances in release technology, efficacy is maintained and is accompanied by an improved adverse events profile. I’m far from convinced. Haven’t we been down this road before with other psychotropic medication classes? The psychostimulants certainly come to mind.

This ongoing trend of pharmaceutical companies to develop long-acting formulations from existing immediate-release medications and then, if gaining FDA approval, marketing them as “new” drugs is shallow. They’re not new drugs, and for that matter, neither is the technology. Intuniv and Trazodone Extended-Release are apt representatives of this disturbing trend.

Joseph Wegmann, R.Ph., LCSW is a licensed clinical pharmacist and a clinical social worker with more than thirty years of experience in the field of psychopharmacology. His diverse professional background in psychopharmacology and counseling affords him a unique perspective on medication management issues. In addition to consulting with numerous psychiatric facilities, he has presented psychopharmacology seminars to thousands of clinicians in 46 states.

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