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Rhodes Pharmaceuticals Announces Launch of New, Once-Daily Treatment for ADHD
Date:5/22/2015

COVENTRY, R.I., May 22, 2015 /PRNewswire/ -- Today, Rhodes Pharmaceuticals L.P. announced that Aptensio XR, a once-daily central nervous system stimulant indicated for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) will be available to patients beginning Summer 2015.

The announcement comes just one month after Aptensio XR received approval from the U.S. Food and Drug Administration (FDA).

Aptensio XR is an extended-release formulation of methylphenidate capsule with an onset of effect of 1 hour and 12-hour duration of effect with approximately 40% of the active ingredient released immediately and approximately 60% delivered later in the day.

Aptensio XR can be taken with or without food. It can also be taken whole, or the capsule can be opened and the contents sprinkled onto applesauce.

"While there are a number of treatment options available for patients with ADHD, there continues to be an unmet need as many patients struggle to achieve symptom control," said Robert Kupper, PhD, Vice President and Chief Technology Officer, Rhodes Pharmaceuticals. "We were encouraged that the Aptensio XR's extended-release formulation helped to control symptoms throughout a 12-hour day, and that it's now another option physicians may consider for their patients."

Aptensio XR was approved by the FDA based on data from two Phase III, randomized, double-blind, placebo-controlled studies evaluating the safety and efficacy of Aptensio XR in children and adolescents with ADHD. The first study, conducted at the Child Development Center, University of California at Irvine, CA "demonstrated that Aptensio XR delivered statistically significant results, from hour one to hour 12 when compared with placebo, as measured by total scores on the Swanson, Kotkin, Agler, M-Flynn, Pelham (SKAMP) Scale," said Sharon Wigal, PhD, Principal Clinical Trial Investigator and Clinical Professor of Pediatrics.

To address patients' needs for individualized treatment, once-daily Aptensio XR is available in seven dose strengths (10, 15, 20, 30, 40, 50 and 60 mg). In the second Phase III study, which included children and adolescents aged six to 17, Aptensio XR consistently demonstrated efficacy across the different doses, as measured by the Attention-Deficit/Hyperactivity Disorder Rating Scale-IV (ADHD-RS-IV).

"As optimal treatment of ADHD is determined patient by patient, the efficacy across dosage strengths seen in the Aptensio XR data is promising," said Akwete Adjei, PhD, Executive Director, Product Development, Rhodes Pharmaceuticals. "The seven dosing options with Aptensio XR allows doctors to fine-tune treatment based on patient needs without sacrificing control and without a further need for a midday dose of immediate-release methylphenidate to sustain safety and efficacy."

The patient-reported adverse events experienced by >2% of patients in the Phase III trials were commonly-known effects of methylphenidate including headache, insomnia, upper abdominal pain, decreased appetite, nausea, vomiting and dizziness.

"We were encouraged by the satisfactory clinical efficacy data for Aptensio XR," said Ann Childress, MD, President, Center for Psychiatry and Behavioral Medicine in Las Vegas, NV and lead investigator. "With an onset as soon as one hour and a duration of up to 12-hours, Aptensio XR will likely be viewed as a welcome new treatment option for physicians treating patients with ADHD."

"The availability of Aptensio XR is an important next step for Rhodes Pharmaceuticals," said Vincent Mancinelli II, President, Rhodes Pharmaceuticals. "We are dedicated to helping to meet patients' unmet needs and are proud that Aptensio XR will help meet the needs of those in the ADHD community."

For more information, visit www.AptensioXR.com.

About ADHD

ADHD is one of the most common neurodevelopmental disorders affecting more than six million children in America.[1] ADHD is usually first diagnosed in childhood and often lasts into adulthood. Children with ADHD may have trouble paying attention, controlling impulsive behaviors (may act without thinking about what the result will be), or be overly active.[2]

About Rhodes Pharmaceuticals

Rhodes Pharmaceuticals L.P. is a specialty pharmaceutical company based in Coventry, Rhode Island. Rhodes Pharmaceutical's vision for success is based on a sustainable business platform, competitive costs, high-quality products, reliable supply, excellent customer service, and a vertically integrated and robust pipeline. For more information, visit www.rhodespharma.com.

Indication

Aptensio XR™ (methylphenidate HCl extended-release) is a central nervous system stimulant prescription medicine. It is used for the treatment of Attention Deficit Hyperactivity Disorder (ADHD).

IMPORTANT SAFETY INFORMATION

Aptensio XR is a federally controlled substance (CII) because it can be abused or lead to dependence. Keep Aptensio XR in a safe place to prevent misuse and abuse. Selling or giving away Aptensio XR may harm others and is against the law.

Tell your physician if you, your child, or any family members have ever abused or been dependent on alcohol, prescription medicines, or street drugs.

Aptensio XR should not be taken if you or your child are allergic to methylphenidate hydrochloride, or any of the ingredients in Aptensio XR, or are taking or have taken within the past 14 days an antidepressant called a monoamine oxidase inhibitor (MAOI).

Heart-related problems have been reported with methylphenidate hydrochloride and other stimulant medications:

  • Sudden death in patients who have heart problems or heart defects
  • Stroke and heart attack in adults
  • Increased blood pressure and heart rate

Your physician should check your or your child's blood pressure and heart rate regularly during treatment with Aptensio XR.

Psychiatric disorders have been reported with methylphenidate hydrochloride and other stimulant medications:

All Patients

  • New or worse behavior and thought problems
  • New or worse bipolar illness

Children and Teenagers

  • New psychotic symptoms, such as hearing voices, believing things that are not true, and being overly suspicious
  •  New manic symptoms

Circulation problems in fingers and toes (peripheral vasculopathy, including Raynaud's phenomenon) have been reported with methylphenidate hydrochloride and other stimulant medicines:

  • Fingers or toes may feel numb, cool, painful, or may change color from pale, to blue, to red

Call your physician right away if you or your child experience any heart-related symptoms, such as chest pain, shortness of breath or fainting, new or worsening mental (psychiatric) symptoms or new manic symptoms, or signs of unexplained wounds appearing on fingers or toes while taking Aptensio XR.

Aptensio XR may not be right for you or your child. Before starting Aptensio XR tell your or your child's physicians about all health conditions (or a family history of) including:

  • Heart problems, heart defects, high blood pressure
  •  Mental problems, including psychosis, mania, bipolar illness, or depression
  • Circulation problems in fingers and toes
  • If you are pregnant or plan to become pregnant. It is not known if Aptensio XR will harm your unborn baby. Talk to your doctor if you are pregnant or plan to become pregnant
  • If you are breastfeeding or plan to breast-feed. Aptensio XR passes into your breast milk. You and your doctor should decide if you will take Aptensio XR or breast-feed

Possible serious side effects of Aptensio XR are heart-related problems, psychiatric disorders, circulation problems in fingers and toes, and slowing of growth (height and weight) in children. Children should have their height and weight checked often while taking Aptensio XR. Aptensio XR treatment may be stopped if a problem is found during these checkups. Painful and prolonged erections (priapism) have occurred with methylphenidate. If you or your child develop priapism, seek medical help right away. Because of the potential for lasting damage, priapism should be evaluated by a physician immediately.

Common side effects include:

  • Decreased appetite
  • Weight loss
  • Nausea
  • Stomach pain
  • Indigestion
  • Dry mouth
  • Vomiting
  • Trouble sleeping
  • Anxiety
  • Nervousness
  • Restlessness
  • Mood swings
  • Agitation
  • Irritability
  • Dizziness
  • Vertigo
  • Shaking (tremor)
  • Blurred vision
  • Increased blood pressure
  • Fast heart beat
  • Increased sweating
  • Fever

Talk to your physician if you or your child have side effects that are bothersome or do not go away.

This is not a complete list of possible side effects. Ask your physician or pharmacist for more information.

Please see Full Prescribing Information.

ADH-9-00061-1

[1] http://www.cdc.gov/ncbddd/adhd/data.html

[2] The ADHD Molecular Genetics Network. Report from the third international meeting of the attention-deficit hyperactivity disorder molecular genetics network. American Journal of Medical Genetics, 2002, 114:272-277.

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SOURCE Rhodes Pharmaceuticals L.P.
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