Vyvanse – ADD and ADHD Medicine Company Analysis

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Table of Contents

Introduction
Vyvanse – The ADD/ ADHD Medicine
Conclusion
Works Cited

Introduction

Background of the study

Vyvanse is the brand name for Lisdexamfetamine Dimesylate which is a single daily dose drug that has been approved by the Food and Drug Association (FDA) for the treatment of the symptoms of Attention Deficit Disorder or Attention Deficit Hyperactivity Disorder (ADD/ADHD) in adults and children aged 6-12 years old (Handelman par.1). Additionally, Vyvanse is a neurostimulant that affects the central nervous system directly through the neurotransmitters and the nerves involved in controlling impulse and hyperactivity (Handelman par.1). It is produced by Shire and New River Pharmaceuticals in its inactive form (pro-drug) which has to undergo digestion in the stomach and through the first-pass metabolic effect in the liver into L-lysine, an amino acid and dextroamphetamine, which is the active form of the drug that treats ADHD (Rosack, p. 1). Besides, the drug is available in all pharmacies across the United States in order to reach out to about 4.4 million children aged 4-17 years old who are suffering from ADHD.

Statistics provided by CDC indicate that the number of children reported to have been diagnosed with ADHD during their life-time represents about 7.8% of all school-going children in the United States. ADHD is a neuropsychological disorder that is common among children and adolescents and it manifests itself in a series of attention problems, hyperactivity in children and impulsivity that can be severe than in normal cases. Diagnosis of the disorder involves observation of the symptoms related to hyperactivity/impulsivity which normally occur before age 7 years in many children. Research also documents that there is no cure for the disorder except for the numerous medications which are usually combined with educational and psychological interventions in modifying the symptoms of the disorder (Wilens, pp. 2-6).

This paper seeks to analyze the appeals, claims, supports and warrants that have been raised in order to justify the application of Vyvanse as a possible remedy in the treatment of ADHD/ADD in adults and children. Additionally, the paper creates a persuasive discourse that utilizes the modes of appeal, supports, claims and warrants. In this case, the paper will be based on the analysis of the arguments documented in order to support this case.

Vyvanse – The ADD/ ADHD Medicine

Approval of Vyvanse by FDA

Vyvanse was approved after clinical studies through reports of mothers with children suffering from ADHD indicated that the drug could achieve control over the ADHD symptoms consistently for more than 12 hours. In these studies, about 121 mothers were assigned the responsibility of submitting their reports 3 times a day; at 10 a.m., at 2 p.m. and at 6 p.m. The results from these studies indicated that about 40% of the subjects reported that the termination of the effect of the medication occurred before 4 p.m. while approximately 60% of the subjects indicated that the effect could last up to 6 p.m. (Waknine par.3). These results were generated from the data collected during the phase II and phase III of the clinical trials involving human subjects. During these studies, the active constituent of the drug, Lisdexamfetamine Dimesylate was used at three strengths; 30mg, 50mg and 70mg. It is documented that the test drug generated statistically significant data indicating that it achieved improvement of the ADHD symptoms over a period of 12 hours relative to the placebo (a simulated medical intervention that produces improvement of a medical condition that is not attributable to any medication). In another phase II study that involved tests carried out on school-age children, the use of the active form of the drug or salts (analogs) that consisted of amphetamine such as Adderall XR, there was observable improvement of the symptoms of ADHD among the children relative to the placebo. This also involved improvement of the academic output especially in solving mathematical exercises (Waknine par.8). Further studies that concurred with these results were carried out during the phase III clinical human trials. During this stage, a one month study was conducted using the three strengths of the active ingredient in a randomized test that also involved use of the control drug and the placebo. All the three dosage levels recorded improved symptoms of ADHD for the Lisdexamfetamine Dimesylate compared to the effects of the control and the placebo. The subsequent 6-12 month study involving daily treatment with the drug recorded that there was a 60% improvement of the symptoms of ADHD in addition to a 95% improvement of the behavior of the children patients (Handelman par.10).

The significance of these studies was to demonstrate that the drug is capable of achieving improved symptoms of ADHD for up to 12 hours a day. This is important for the school-age children suffering from this disease since despite the fact that the drug helps them to accomplish their academic activities during day-time; the same effect is also needed to allow the kids to carry out their homework and still spend some time with other family members after school. Moreover, Vyvanse coordinates with an individual’s metabolic processes in delivering the active constituents of the drug to target sites thereby achieving improvement of the physiological and psychological functions that are affected by ADHD such as behavior, listening and focus.

The characteristics of Vyvanse that guarantee safety and efficacy to patients relative to other related medications

As earlier indicated, Vyvanse is a pro-drug in which the active ingredient, d-amphetamine is conjugated with the amino acid L-lysine. It is administered orally whereby it is well tolerated in many patients. The drug undergoes digestion in the stomach and absorption through the intestinal tract into the liver whereby it undergoes the first-pass effect in which case the hepatic enzymes break it down into L-lysine, which contains no therapeutic effect and d-amphetamine, which is the active component of the drug that treats ADHD (Rosack 1). Research indicates that d-amphetamine is a therapeutic remedy that is characteristically different from other abused stimulants which has been employed in the treatment of ADHD for many years. This drug component occurs in the market under other brand names such as Dexedrine and Dextrostat (Handelman par.2).

Due to the necessity of enzymatic digestion of the pro-drug before achieving therapeutic potential, Vyvanse is rarely abused. Therefore, when drug and substance abusers try to snort or inject the drug into their bodies, the same effect as that observed with other abused drugs is not achieved or may not be felt. In a study undertaken by Shire/New River Pharmaceuticals on human substance abusers, the drug achieved a value for the Drug Liking Effects (DLE) that was less than that recorded with the use of pure d-amphetamine of the same dosage. These statistically significant and testable data results have guaranteed the drug the full FDA and DEA approval as a safe medication for the treatment of ADHD. However, there are claims that the drug can also be activated in the bloodstream into its active ingredient but there are no scientifically proven materials to support the claim.

Additionally, Vyvanse contains other characteristics which make the drug user-friendly. It occurs as a capsule which can be swallowed wholly by adults or mixed with water and given to young children. Moreover, the drug occurs in various strengths such as 20mgs, 30mgs, 40mgs up to 70 mgs which offer the physician and the patient the flexibility of choosing the right dosage. It is also worth noting that the drug is prescribed once a day but guarantees 13 hours of improved symptoms of ADHD (Handelman par.6).

Side Effects

Despite of the numerous advantages that the drug presents to its users, it is worth noting that Vyvanse like most other stimulants has side effects on the users. These include: difficulties with sleeping, lose of appetite, irritability, mild stomachaches and emotional lability. It should however be noted that these side effects decrease or disappear with time and in case of prolonged side effects or severity, patients are advised to seek medical attention.

Contraindications

Patients and the general public are advised to avoid using Vyvanse together with the MonoAmineOxidases (MAOs) such as Marplan, Parnate or Emsam among others. And if a patient uses any of these MAOs, he/she should avoid using Vyvanse until after two weeks. This is because; patients may experience the occurrence of severe side effects due to cross-reactivity of the two families of stimulants. Patients who are allergic to the active component in Vyvanse, Lisdexamfetamine are advised to avoid using the medication. Moreover, patients who maybe suffering from other complications such as arteriosclerosis, hypertension, heart diseases, alcoholism, severe anxiety among others are not advised to use this medication. Some of these medications are reported to have caused death in some patients and thus patients are advised to open up to their physicians and tell them about their heart diseases or any other diseases before they accept Vyvanse to be prescribed. However, it is imperative to note that Vyvanse is highly tolerated drug among many patients who have used it.

Conclusion

This paper has given an in-depth analysis of the appeals, supports, claims and warrants documented in support of the use of Vyvanse for the treatment of ADHD in children and adults. As indicated, the drug has passed through all the stages of drug testing and generated positive results which have guaranteed its full FDA and DEA approval. Besides, the drug has numerous characteristics which make it user friendly and tolerable. One notable characteristic is that the drug requires enzymatic activation in the liver before it exerts its therapeutic effects. This makes it almost impossible for drug and substance abusers to snort or inject it into their bodies.

Despite of the fact that the drug has numerous advantages, it is noted that it has a number of side-effects particularly stomachaches and causing lack of sleep. Additionally, it is noted that the drug should not be prescribed for patients who may be suffering from other complications which may be exacerbated by the administration of Vyvanse. Otherwise, Vyvanse is a tolerable drug among many patients and it has gained the confidence of many physicians and patients since it is considered an alternative remedy for the treatment of ADHD.

Works Cited

Handelman, Kenny. Vyvanse – the new medicine for ADD/ADHD. Medical Integrity Inc, 2008.
Rosack, Jim. Clinical & Research news: novel drug for ADHD wins FDA approval. Psychiatric News. American Psychiatric Association; 42(7): 1, 2007.
Wilens, Timothy E. Straight talk about psychiatric medications for kids. New York: Guilford Publication Press, 2009.
Waknine, Yael. FDA approvals: Cymbalta, Vyvanse, Kadian. Medscape Medical News: Medscape, LLC., 2010.

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