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New FDA-Approved Drug

New FDA-Approved Drug

The FDA (Food Drug Administration) is a federal agency under the health department that ensures the safety, efficacy, and security of human drugs. An FDA approval is an updated review of the effects of drugs, benefits, and risks associated with a drug. Approval is done by analyzing the disease managed by the drug and other alternative drugs available in the market. The process also outweighs the risks and benefits of the drugs and prepares for anticipated risks (Gharaghani et al., 2020). Nurtec oral disintegrated tablet ODT is a rimegepant calcitonin gene-related-petite receptor that has been newly approved by the FDA for the management of migraine headaches (Lazim et al., 2020).

Pharmacodynamics and Pharmacokinetic Properties of Nurtec ODT          

Pharmacodynamics is a branch of pharmacology that describes the mechanism of action and the effects of drugs (Stock et al., 2019). Nurtec ODT induces endothelium-independent vasodilation through a direct action on vascular smooth muscle cells in cerebral and coronary vascular beds. It can reduce brain ischemia and coronary heart disease and relieve a migraine headache with or without aura.

Pharmacokinetics describes the time course of the medicine, absorption, distribution, metabolism, and excretion of a drug. Nurtec ODT has a plasma half-life of 11 hours with 64% oral bioavailability and 96% plasma bioavailability. The medicine is absorbed within one hour. Its absorption is usually delayed if the patient has taken fatty food within one hour of taking the drug. The drug is metabolized by the CYP3A4 and, to a lesser extent, by the CYP2C9. It is distributed in the body through a plasma-binding protein of rimegepant, which is approximately 96%. The drug is eliminated in unchanged form and excreted 11 hours following administration. 51% is excreted in urine, and 42% is excreted in feces (Stock et al., 2019).

Nurtec is prescribed as 75mg once daily, and its intake should not exceed 75mg in 24 hours. There are no known effects on pregnant patients and pediatrics. It should, however, be avoided in hepatic, renal disease, and end-stage renal disease. The medicine is administered orally or sublingually and should be taken immediately after tearing the foil (Stock et al., 2019).

Migraine Headache

A migraine headache is a neurovascular disorder characterized by a diffuse headache, throbbing in nature, and lasting from a few hours to a few days (Lipton et al., 2016). It is associated with hypersensitivity to light and sound, nausea, and vomiting and is more prevalent in women than in men.

Migraine headache passes through four phases; prodromal, aura, headache, and postdrome (Lipton et al. 2016). The prodromal phase starts two days before the onset of headache. It presents with signs of irritability, depression, neck stiffness, and food cravings. The aura phase presents with a flashlight or blind spot in the eye with numbness and weakness in one side of the body that lasts minutes to hours. Aura presents a few hours before the headache. The headache phase presents with photophobia attacks that are relieved by sleeping in a dark room. The postdrome phase presents with a headache on sudden exertion, extreme tiredness, and exhaustion.

Risk factors associated with a migraine headache are psychological stress, hormonal changes, stimuli like loud noise, bright light and strong scent, change of weather, and change in sleep patterns. Migraine headache is managed in two phases; abortive therapy and prophylactic therapy. An abortive therapy is meant to relieve the patient from pain, while prophylactic therapy aims to reduce the frequency and severity of the disease. Abortive therapy may involve; NSAIDs, triptans, and lasmiditan. Prophylactic therapy agents are; beta-blockers, anticonvulsants, antidepressants, and calcium channel blockers. Differential diagnoses are transient headache, cluster headache, and transient ischemic attack. Its complications are persistent aura with infarction, mental health illness, status migrainosus, and migraine-aura-triggered seizures (Lipton et al., 2016).

The Difference Between, Rimegepant and Other Currently Available Therapies

The drugs currently available for migraines are non-steroidal anti-inflammatory drugs, NSAIDs, triptans, opioids, and acetaminophen (Lazim et al., 2019). Compared to rimegepants, these drugs have more adverse effects. Calcitonin gene-related peptide CGRP is found to be the best in the management of migraine headaches. Patients treated with triptans developed cardiovascular diseases related to vasoconstriction effects. Non-steroidal anti-inflammatory drugs cause digestive ulcers. CGRP and olcegepant have good efficacy, and their serum bioavailability is directly proportional to the migraine. However, olcegepant has relatively high toxicity making rimegepant safer. Rimegepants relives the pain within two hours of administration. Commonly reported adverse effects are dizziness, nausea, hepatic injury, and urinary tract infection. Rimegepants have good efficacy and safety for the acute management of acute migraine headaches by relieving pain within two hours after administration, and the dosage is not related to a significant increase in adverse effects.

Potential Risk Associated With Rimegepant and Its Parameters

Rimegepant is used to manage headaches with aura or without aura (Stock et al., 2019). The drug does not prevent the occurrence of migraines. Risks associated with rimegepant are liver disease and end-stage renal disease. This drug should not be prescribed to patients less than 18 years. In pregnant women, migraine headaches may lead to serious complications like high blood pressure that threaten the life of the mother and the unborn child. The benefit of rimegepant outweighs the risks (Lazim et al., 2019). The safety of the drug in lactation is not yet established. The most common side effect is hypersensitivity, which may happen immediately or days later after taking the medication. This allergic reaction causes swelling of the face, lips, and eyes, hives, rash, and difficulty breathing. Other effects are nausea and vomiting.

Why I Would Prescribe This Drug Instead of Other Agents

I would prescribe Nurtec ODT because of its efficacy. It relieves pain within two hours of administration, has few tolerable side effects, unlike other drugs with life-threatening complications, and is readily available and affordable. Additionally, it does not have a lot of drug interactions compared to other drugs. This drug does not have associated addictions like the opioid group of drugs. In addition, Nurtec ODT does not necessarily need water to be administered, and its package is completely sealed, making it safe for consumption. Nurtec ODT is a newly approved drug by the FDA. It is safe for use and much more effective compared to other drugs on the market.


Gharaghani, Haider,  Jafaripour, Nazarshodeh, & Saboury. (2020). Silico drug repositioning of FDA-approved drugs to predict new inhibitors for alpha-synuclein aggregation. Computational Biology and Chemistry88, 107308

Lazim, DeFalco, & Cope. (2020). Nurtec Orally Disintegrating Tablet and Migraine Treatment: Book Review.  Pharmacotherapy, 1060028020954800

Lipton, Silberstein, Cady, Dorlas, & Saper, (2016) Migraine headache with aura and noninvasive vagus nerve stimulation: The EVENT study. Neurology87(5), 529-538.

Stock, Conway, Forshaw, Stock, & Lipton, (2019) Safety, tolerability, and efficacy of Nurtec ODT for management of migraines The Lancet394(10200), 737-745


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New FDA-Approved Drug

Choose a drug that has been approved by the FDA within the past year.

Write a 1,000-1,250 word paper in which you:

  1. Describe the drug approved by the FDA. Include the pharmacodynamics and pharmacokinetic properties of the chosen drug.

    New FDA-Approved Drug

    New FDA-Approved Drug

  2. Provide an overview of the disease state for which the drug is used.
  3. Describe what is different about this agent compared to currently available therapies.
  4. Discuss the potential risks associated with this agent and any monitoring parameters that are necessary.
  5. Decide whether you would personally prescribe this agent or stick with currently available alternatives.

You are required to cite five to 10 sources to complete this assignment. Sources must be published within the last 5 years and appropriate for the assignment criteria and nursing content.

Prepare this assignment according to the guidelines found in the APA Style Guide, located in the Student Success Center. An abstract is not required.

This assignment uses a rubric. Review the rubric prior to beginning the assignment to become familiar with the expectations for successful completion.

You are required to submit this assignment to LopesWrite. Refer to the LopesWrite Technical Support articles for assistance.

This assignment benchmarks the following competencies:

    • 6.3: Assess the pharmacodynamics and the pharmacokinetic impact of pharmacologic therapies in the treatment of diseases and altered states.
    • 7.3: Prescribe appropriate pharmacologic and nonpharmacologic therapies in the management of illness, disease, or injuries.
    • 6.3: Assess the pharmacodynamics and the pharmacokinetic impact of pharmacologic therapies in the treatment of diseases and altered states.
    • 7.3: Prescribe appropriate pharmacologic and nonpharmacologic therapies in the management of illness, disease, or injuries.

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