Mental Health Clinician Volume 4: Issue 1

When ‘new’ psychotropic medications are released on the market, it can be difficult to discern the differences between the newer agents and their similar predecessors. Since head to head clinical trials are rarely available, it is important to learn what can be gleaned from the package inserts and the Food and Drug Administration (FDA) website. These sources are a wealth of information and were used as the primary resources for the comparative tables that follow.

Table 4.Bupropion Products¹¹

Adderall XR^® (MAS XR) and Vyvanse™ (LDX) are both schedule II amphetamine-based central nervous system stimulants indicated for the treatment of attention-deficit/hyperactivity disorder. Differences among the two primarily involve dosage form, pharmacokinetic profiles, and abuse potential. MAS XR and LDX are both long-acting stimulants with an approximate duration of action of 10 hours. The long-acting property of LDX is secondary to its prodrug formulation, whereas MAS XR utilizes bead filled capsules that mimic twice daily dosing upon administration. MAS XR is a substrate of CYP 2D6 while LDX does not utilize the cytochrome P450 enzymes for metabolism. There are few efficacy studies that directly compare LDX and MAS XR. There are no head to head abuse liability studies for MAS XR and LDX; however, the prodrug formulation of LDX is proposed to have lower abuse potential.

Antidepressant drug development first began in the mid-twentieth century with the discovery of monoamine oxidase inhibitors and tricyclic antidepressants. Soon after, additional molecular targets and drug entities were created, eventually leading to the development of selective serotonin reuptake inhibitors. Today, antidepressants now rank among the top 10 most commonly used medications in the United States (US) and account for over $11 billion in annual sales. To help ensure the safety and efficacy of these commonly used products, in 1977 the US Food and Drug Administration (FDA) created guidelines to standardize antidepressant studies and the approval process. Although many of the recommendations outlined by FDA are still relevant, the document remains vague when describing key aspects of antidepressant trial design and much of the clinical information is outdated by today's standards. This paper will provide a general overview of the FDA-approval process, summarize FDA's position related to antidepressant trial design, and discuss the need for updates in the approval process.

Buprenorphine and buprenorphine/naloxone sublingual tablets were approved by the FDA in 2002. In 2010, the buprenorphine/naloxone sublingual film was approved to address concerns of diversion, time for tablet dissolution, and unintentional exposure in children with the tablet. This article will compare the buprenorphine sublingual formulations in terms of pharmacokinetics, safety, diversion and misuse, cost, and patient preference. It will explore current data suggesting advantages or disadvantages of the various formulations since conclusive data are minimally available.

What's new? Isomers, metabolites and prodrugs, oh my!

What is the difference? Within class comparisons of psychotropic agents with new products

Adderall XR® and Vyvanse™

Antidepressant medications: The FDA-approval process and the need for updates

Buprenorphine for opioid dependence: Are there really differences between the formulations?

Clonidine and guanfacine IR vs ER: Old drugs with “new” formulations

Levomilnacipran (Fetzima^™) for the treatment of major depressive disorder

Therapeutic drug monitoring with valproate–Why product selection is an important factor

Key differences between Venlafaxine XR and Desvenlafaxine: An analysis of pharmacokinetic and clinical data

Buprenorphine for opioid dependence: Are there really differences between the formulations?

Antidepressant medications: The FDA-approval process and the need for updates

Key differences between Venlafaxine XR and Desvenlafaxine: An analysis of pharmacokinetic and clinical data

Therapeutic drug monitoring with valproate–Why product selection is an important factor

What's new? Isomers, metabolites and prodrugs, oh my!