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

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 (Ritalin) or dextroamphetamine (Adderall) 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.

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 about Intuniv and Trazodone Extended Release? Not much. The release technology certainly isn’t, and as far as the improved side effects profile goes, maybe. They’re certainly no more effective than the immediate release products.

This trend of some pharmaceutical companies toward the development of long-acting formulations from existing immediate-release medications and then selling them as something new or novel is pretty shallow. They’re “new” in name only (translation: BRAND NAME BUCKS).

Other examples of – Not Really New –

By tweaking the chemistry of Celexa, the drug Lexapro – a serotonin antidepressant blockbuster – was born. The antidepressant Pristiq has been described by many as no more than a “patent extender” for another big seller- Effexor XR. The antipsychotic Invega is a clone of Risperdal, and Vyvanse has become the hot oral psychostimulant for ADHD, with sales eclipsing that of its predecessor, Adderall XR.

Big Pharma companies are eschewing new drug development because they’re taking a “why buy the cow when you can get the milk anyway” approach. It takes tens of millions of dollars in research and development and several years of toil to get a new drug to market, with no guarantees. And increasingly, in late-stage clinical trials, these upstart hopefuls aren’t consistently outperforming placebo. So in effect, these companies are selling retreads at brand-name prices.

This means there’s nothing new under the sun, for now at least. And it’s likely to stay that way until advances in neuroscience are able to clarify the underlying pathology of mental disorders thereby paving the way for taking the guesswork out of what drug will work for whom. This will ease the burden on truly new drug development.

The day will come when a clinician, faced with a client who has major depression, will be able to order a gene scan that will predict response to a certain medication.

Now that’s advancement!

————————————————————

Joe Wegmann is a licensed clinical social worker and a clinical pharmacist with over 30 years of experience in counseling and medication treatment of depression and anxiety. Joe’s new book, www.thepharmatherapist.com, or e-mail him at joe@thepharmatherapist.com.