Media

Published on August 12, 2015

CHARLOTTE, N.C., August 13, 2015; –

FSC Pediatrics announced today the launch of Karbinal^™ ER, the only 1^st generation extended-release oral suspension antihistamine available in U.S. Karbinal ER is an H1 receptor antagonist (antihistamine) indicated for two years of age and older. The availability of Karbinal ER provides physicians with a new, effective and easy to use treatment option for children with seasonal and perennial allergic rhinitis that need symptomatic relief for runny nose, sneezing, itchy nose or throat and itchy and watery eyes.

Allergic rhinitis affects the lives of over 50 million Americans as it is the third leading cause of chronic illness among children under the age of 18 years old in the U.S. Children account for 40 percent of those suffering from allergic rhinitis, resulting in 6.6 million pediatric diagnoses in 2012 alone.¹ Despite abundant treatment options, there still remains an overall unmet need and dissatisfaction with medications. Based on an Asthma and Allergy foundation of America survey, 88% say an important feature of prescription allergy medication is that it provides long-lasting relief of symptoms, 60% of all allergic rhinitis patients surveyed responded that they are “very interested in finding a new medication, 31% are not fully satisfied with their current prescription medication and 26% are constantly trying new medications.²

“The addition of Karbinal ER to our portfolio of products further demonstrates our commitment to meeting unmet needs of pediatric patients. We look forward to bringing Karbinal ER to the millions of pediatric allergy sufferers.” said Peter W. Steelman, President and Chief Executive Officer at FSC Pediatrics.

“The launch of Karbinal ER demonstrates the continued success of our OralXR+ technology and is representative of Tris’ history of developing and manufacturing first-to-market liquid sustained-release products that fill significant unmet patient needs,” added Ketan Mehta, President and CEO of Tris Pharma.

Steelman added, “We’re excited to be partnered with Tris Pharma to make this pleasant-tasting, extended-release liquid formulation of carbinoxamine, an antihistamine with years of proven safety and efficacy, available for patients as young as two years old.”

IMPORTANT SAFETY INFORMATION FOR KARBINAL ER:

CONTRAINDICATIONS:

• Children younger than 2 years of age
• Nursing mothers
• Patients with known hypersensitivity to the drug or any of its inactive ingredients
• Patients taking monoamine oxidase inhibitors (MAOI)

WARNINGS AND PRECAUTIONS:

• Deaths have been reported in children less than 2 years of age who were taking carbinoxamine-containing drug products. Do not give Karbinal ER to children younger than 2 years of age.
• Caution patients to avoid engaging in hazardous tasks requiring mental alertness and motor coordination, such as driving or operating machinery.
• Use with caution in patients with increased intraocular pressure, narrow angle glaucoma, hyperthyroidism, cardiovascular disease, hypertension, stenosing peptic ulcer, symptomatic prostatic hypertrophy, bladder neck obstruction, or pyloroduodenal obstruction.
• Karbinal ER contains sodium metabisulfite, a sulfite which may cause anaphylaxis and life-threatening or less severe asthmatic episodes in susceptible individuals.

ADVERSE REACTIONS:

• The most common adverse reactions include sedation, sleepiness, dizziness, disturbed coordination, epigastric distress, and thickening of bronchial secretions.

DRUG INTERACTIONS:

• Avoid use of Karbinal ER with monoamine oxidase inhibitors (MAOIs) which prolong and intensify the anticholinergic (drying) effects of antihistamines.
• Avoid use of Karbinal ER with alcohol and CNS depressants (hypnotics, sedatives, tranquilizers, etc.) due to additive adverse effects.

USE IN SPECIAL POPULATIONS:

• Because of the higher risk of mortality in infants, Karbinal ER is contraindicated in children younger than 2 years of age, and in nursing mothers.
• May cause sedation or excitation in young children.
• May cause dizziness, sedation, and hypotension in elderly patients. Start elderly patients on lower doses and observe closely for confusion and over-sedation.

INDICATIONS AND USAGE:
Karbinal^™ ER (carbinoxamine maleate) is indicated for the symptomatic treatment of:

• Seasonal and perennial allergic rhinitis
• Vasomotor rhinitis
• Mild, uncomplicated allergic skin manifestations of urticaria and angioedema
• Dermatographism
• As therapy for anaphylactic reactions adjunctive to epinephrine and other standard measures after the acute manifestations have been controlled
• Amelioration of the severity of allergic reactions to blood or plasma

About FSC:

FSC Pediatrics, Inc., based in Charlotte, NC, is a specialty pharmaceutical and medical device company founded in 2004, solely dedicated to providing innovative solutions to unmet medical needs for pediatric patients across the communities it serves. FSC Pediatrics provides products that meet pediatric-primary care and specialist needs in three therapeutic categories; Infection, Allergy/Asthma, and Gastrointestinal Disease. More information is available at fscpediatrics.com.

About Tris Pharma:

Tris Pharma is a specialty pharmaceutical company focused on the research and development of technologies-driven products. Tris has pioneered the delivery of sustained release in the liquid, chewable/ODT and strip dosage forms so patients do not have to swallow a pill. Tris’ Nobuse^™ technology provides abuse deterrence for opioids and other abuse-prone drugs. Tris’ R&D and manufacturing facilities are located in Monmouth Junction, New Jersey.

*References:
¹“Allergy Facts and Figures.” Asthma and Allergy Foundation of America.
²“New survey reveals many patients want more from their allergy medication.” Asthma and Allergy Foundation of America. Published November 8, 2005. Web.