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FDA Approved Drugs: Changes to Approved Drugs01:26

FDA Approved Drugs: Changes to Approved Drugs

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Post-approval, manufacturers may modify an approved new or generic drug product. Such modifications can encompass alterations in the Active Pharmaceutical Ingredient (API), manufacturing process, formulation, batch size, manufacturing site, and container closure system (FDA Guidance for Industry, April 2004). Often, a drug product may undergo multiple changes.These modifications require careful evaluation to determine their potential impact on the drug product's identity, strength, quality,...
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Management of Insomnia

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The sleep cycle, an integral part of human health, consists of several stages with distinct characteristics and functions. It begins with a transition from wakefulness to sleep, known as the light sleep phase, followed by the restorative deep sleep phase, essential for physical recovery and growth. The cycle concludes with the Rapid Eye Movement (REM) phase, characterized by high brain activity and vivid dreaming. Insomnia, a prevalent sleep disorder, involves difficulty falling asleep, staying...
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Sedatives and hypnotics encompass a wide range of substances, each with its unique mechanism of action, uses, and potential adverse effects.
Melatonin congeners like ramelteon (Rozerem) and tasimelteon (Hetlioz) selectively bind to melatonin receptors (MT1 and MT2) and thus mimic the actions of melatonin, a hormone that regulates sleep-wake cycles. Tasimelteon is primarily used for non-24-hour sleep-wake disorder, common in blind patients. They are also used to treat conditions like insomnia...
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Receptor tyrosine kinase inhibitors (TKIs) and calcium channel blockers (CCBs) are two critical categories of drugs employed in the treatment of pulmonary artery hypertension (PAH). PAH is a disease that causes high blood pressure in the pulmonary arteries, resulting in chest pain, fatigue, and shortness of breath.
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Incretins include glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP), which stimulate insulin secretion post-meals. In type 2 diabetes, GIP's efficacy is reduced, making GLP-1 a viable drug target. GIP originates from preproGIP.
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The NeuroStar TMS Device: Conducting the FDA Approved Protocol for Treatment of Depression
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Tasimelteon: first global approval.

Sohita Dhillon1, Madeleine Clarke

  • 1Adis, Auckland, New Zealand.

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|March 11, 2014
PubMed
Summary

Tasimelteon is a new medication approved for non-24-hour sleep-wake disorder. This melatonin receptor agonist helps reset the body's internal clock, improving sleep-wake cycles.

Area of Science:

  • Pharmacology
  • Chronobiology
  • Neuroscience

Background:

  • Melatonin regulates the human circadian rhythm via MT1 and MT2 receptors.
  • Disruption of circadian entrainment leads to non-24-hour sleep-wake disorder.
  • Endogenous melatonin rhythm indicates human circadian phase.

Purpose of the Study:

  • To summarize the development of tasimelteon.
  • To highlight its approval for treating non-24-hour sleep-wake disorder.

Main Methods:

  • Review of tasimelteon's development milestones.
  • Analysis of its mechanism as a melatonin receptor agonist.

Main Results:

  • Tasimelteon is the first FDA-approved medication for non-24-hour sleep-wake disorder.

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  • It acts as an agonist for melatonin MT1 and MT2 receptors.

    • Conclusions:

    • Tasimelteon offers a novel therapeutic approach for circadian rhythm disorders.
    • Carefully timed administration of tasimelteon can promote circadian readjustment.