PHILADELPHIA, Nov. 9 /PRNewswire-FirstCall/ -- Shire plc , the global specialty biopharmaceutical company, today announced the availability of INTUNIV(TM) (guanfacine) Extended Release Tablets in pharmacies across the United States for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in children and adolescents ages 6 to 17. INTUNIV, a once-daily formulation of guanfacine, is the first and only nonscheduled alpha-2A receptor agonist approved for the treatment of ADHD. In clinical trials, INTUNIV provided significant efficacy across the spectrum of ADHD symptoms that can be disruptive, such as being easily distracted, interrupting others, running around excessively, arguing with adults, and losing temper.
The US Food and Drug Administration (FDA) approved INTUNIV on September 2, 2009. Once-daily INTUNIV is now available in US pharmacies in four dosage strengths (1 mg, 2 mg, 3 mg, and 4 mg) and is marketed in the United States by the existing Shire ADHD sales team of nearly 600 representatives. INTUNIV is not a controlled substance and has no known potential for abuse or dependence.
The commitment of Shire to making INTUNIV available for ADHD patients is consistent with the company’s strategy to expand and diversify its ADHD portfolio, which now consists of four ADHD treatment options of scheduled and nonscheduled medicines in the United States and three medicines approved for the treatment of ADHD outside the United States.
The first pivotal trial was a phase III, double-blind, parallel-group trial, in which investigators randomized 345 children aged 6 to 17 years to either a placebo or a fixed 2-mg, 3-mg, or 4-mg dose of INTUNIV given once daily during an eight-week period. The second pivotal trial was a phase III, double-blind, parallel-group trial, in which investigators randomized 324 children aged 6 to 17 years to either a placebo or a fixed 1-mg, 2-mg, 3-mg, or 4-mg dose of INTUNIV given once daily during a nine-week period, with the 1 mg assigned only to patients weighing less than 50 kg (110 lbs).
Both trials demonstrated statistically significant improvements in ADHD-RS-IV scores in patients taking INTUNIV beginning one to two weeks after patients began receiving once-daily doses of INTUNIV. In the first pivotal trial, the mean reduction in ADHD-RS-IV total scores at end point were -16.7 for INTUNIV compared to -8.9 for placebo (P<.0001); the mean reduction in ADHD-RS-IV total scores in the second pivotal trial were -19.6 for INTUNIV and -12.2 for placebo (P=.0040). Placebo-adjusted LS mean changes from baseline were statistically significant for all INTUNIV doses in the randomized treatment groups in both studies.
Safety was also evaluated during these pivotal trials and safety data showed that adverse events reported by participants using INTUNIV were generally mild to moderate in severity. Treatment-related adverse events greater than 10 percent included somnolence (32 percent), headache (26 percent), fatigue (18 percent), upper abdominal pain (14 percent), and sedation (13 percent). Sedation-related, treatment emergent adverse events were among the most common and were usually transient and mild to moderate in severity. Small to modest changes in blood pressure, pulse rate, and ECG parameters were observed.
Important Safety Information
INTUNIV is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in children and adolescents aged 6 to 17. Efficacy was established in two controlled clinical trials (8 and 9 weeks in duration). The physician electing to use INTUNIV for extended periods should periodically reevaluate its long-term usefulness for the individual patient.
Hypotension, bradycardia, and syncope were observed in clinical trials. Use INTUNIV with caution in treating patients who have experienced hypotension, bradycardia, heart block, or syncope, or who may have a condition that predisposes them to syncope; are treated concomitantly with antihypertensives or other drugs that can reduce blood pressure or heart rate or increase the risk of syncope. Heart rate and blood pressure should be measured prior to initiation of therapy, following dose increases, and periodically while on therapy. Patients should be advised to avoid becoming dehydrated or overheated.
Common adverse reactions in patients taking INTUNIV that may be dose related over the range of 1 to 4 mg/day include somnolence, sedation, abdominal pain, dizziness, hypotension/decreased blood pressure, dry mouth, and constipation.
ADHD is a psychiatric behavioral disorder that manifests as a persistent pattern of inattention and/or hyperactivity-impulsivity that is more frequent and severe than is typically observed in individuals at a comparable level of development. The specific etiology of ADHD is unknown and there is no single diagnostic test for this disorder. Adequate diagnosis requires the use of medical and special psychological, educational and social resources, utilizing diagnostic criteria such as Diagnostic and Statistical Manual of Mental Disorders-IV (DSM-IV(R)) or International Classification of Diseases 10 (ICD-10).
SHIRE PLC
Shire’s strategic goal is to become the leading specialty biopharmaceutical company that focuses on meeting the needs of the specialist physician. Shire focuses its business on attention deficit hyperactivity disorder (ADHD), human genetic therapies (HGT) and gastrointestinal (GI) diseases as well as opportunities in other therapeutic areas to the extent they arise through acquisitions. Shire’s in-licensing, merger and acquisition efforts are focused on products in specialist markets with strong intellectual property protection and global rights. Shire believes that a carefully selected and balanced portfolio of products with strategically aligned and relatively small-scale sales forces will deliver strong results.
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Statements included herein that are not historical facts are forward-looking statements. Such forward-looking statements involve a number of risks and uncertainties and are subject to change at any time. In the event such risks or uncertainties materialize, the Company’s results could be materially adversely affected. The risks and uncertainties include, but are not limited to, risks associated with: the inherent uncertainty of research, development, approval, reimbursement, manufacturing and commercialization of the Company’s Specialty Pharmaceutical and Human Genetic Therapies products, as well as the ability to secure and integrate new products for commercialization and/or development; government regulation of the Company’s products; the Company’s ability to manufacture its products in sufficient quantities to meet demand; the impact of competitive therapies on the Company’s products; the Company’s ability to register, maintain and enforce patents and other intellectual property rights relating to its products; the Company’s ability to obtain and maintain government and other third-party reimbursement for its products; and other risks and uncertainties detailed from time to time in the Company’s filings with the Securities and Exchange Commission.
Shire plc
