Mallinckrodt Announces Approval Of New Gablofen® Prefilled Syringe

Mallinckrodt, the Pharmaceuticals business of Covidien (NYSE: COV), today announced the U.S. Food and Drug Administration (FDA) approval of Gablofen ^® (baclofen injection) in prefilled syringes. The Gablofen prefilled syringe was created to reduce preparation steps, helping to simplify the pump refill process for patients receiving ITB Therapy ^SM (Intrathecal Baclofen Therapy) to treat severe spasticity of cerebral and spinal origin.

“The launch of Gablofen prefilled syringe enhances our product portfolio and provides a known treatment in a convenient delivery technology,” said Mark Trudeau, President, Mallinckrodt. “The prefilled syringe has the opportunity to replace the traditional glass ampules and simplify the pump refill process for healthcare providers treating appropriate patients with severe spasticity.”

A Refill Convenience Kit has been re-designed to include what is needed for pump refills using Gablofen prefilled syringes. It includes snug compartments to help ensure that each component stays in place.

Gablofen was developed by CNS Therapeutics, which was recently acquired by Mallinckrodt. Gablofen prefilled syringes will be available in February 2013. Gablofen is currently available in ready-to-use vials in the following concentrations: 50 mcg/mL (screening dose), 500 mcg/mL, new 1,000 mcg/mL and 2,000 mcg/mL. Gablofen 1,000 mcg/mL, introduced in 2012, was the first new refill concentration added in 20 years.

PLEASE SEE IMPORTANT RISK INFORMATION, INCLUDING BOXED WARNING BELOW.

SEE LINK TO FULL PRESCRIBING INFORMATION FOR ADDITIONAL IMPORTANT RISK INFORMATION.

INDICATIONS AND USAGE

• Gablofen (baclofen injection) is a gamma-aminobutyric acid (GABA) ergic agonist indicated for use in the management of severe spasticity of cerebral or spinal origin in adult and pediatric patients age 4 years and above.
• Gablofen should be reserved for patients unresponsive to oral baclofen therapy, or those who experience intolerable central nervous system side effects at effective doses.
• Patients should first respond to a screening dose of intrathecal baclofen prior to consideration for long term infusion via an implantable pump.
• Spasticity due to traumatic brain injury: wait at least one year after injury before considering Gablofen therapy.

IMPORTANT RISK INFORMATION

WARNING: DO NOT DISCONTINUE ABRUPTLY

Abrupt discontinuation of intrathecal baclofen, regardless of the cause, has resulted in sequelae that include high fever, altered mental status, exaggerated rebound spasticity, and muscle rigidity, that in rare cases has advanced to rhabdomyolysis, multiple organ-system failure and death. Prevention of abrupt discontinuation of intrathecal baclofen requires careful attention to programming and monitoring of the infusion system, refill scheduling and procedures, and pump alarms. Patients and caregivers should be advised of the importance of keeping scheduled refill visits and should be educated on the early symptoms of baclofen withdrawal. Special attention should be given to patients at apparent risk (e.g. spinal cord injuries at T-6 or above communication difficulties, history of withdrawal symptoms from oral or intrathecal baclofen). Consult the technical manual of the implantable infusion system for additional post-implant clinician and patient information.

CONTRAINDICATIONS:

• Hypersensitivity to baclofen.
• Do not use Gablofen for intravenous, intramuscular, subcutaneous or epidural administration.

WARNINGS AND PRECAUTIONS

• Use only with Medtronic SynchroMed ^® II Programmable Pump (or other pumps labeled for intrathecal administration of Gablofen (baclofen injection))
• Risk of life-threatening overdose during pump refills. Use extreme caution when filling the Medtronic SynchroMed ^® II Programmable pump which is equipped with an injection port that allows direct access to the intrathecal catheter. Direct injection into the catheter through the catheter access port may cause a life-threatening overdose.
• Resuscitative equipment and trained staff must be available during screening dose, dose titration, and refills due to the potential life-threatening CNS depression, cardiovascular collapse, and/or respiratory failure.
• Overdose may cause drowsiness, lightheadedness, dizziness, somnolence, respiratory depression, seizures, rostral progression of hypotonia and loss of consciousness progressing to coma.
• Use with caution in patients with psychotic disorders, schizophrenia or confusional state as it may exacerbate condition(s).
• Fatalities have been reported with intrathecal baclofen use.
• Caution should be used in patients with a history of autonomic dysreflexia.
• Presence of infection may increase the risk of surgical complication and complicate dosing of Gablofen.
• May cause drowsiness: use caution in operation of automobiles, dangerous machinery and activity that made hazardous by decreased alertness. Other CNS depressants and alcohol may add to this effect.
• Potential development of intrathecal mass formation. Clinicians should monitor for signs and symptoms of new neurologic symptoms including the use of imagining diagnostic modalities.
• Oral baclofen use has been associated with a dose related increase in incidence of ovarian cysts.
• Pregnancy Category C. The effect of baclofen in labor and delivery is unknown
• Balcofen is excreted into breast milk at oral therapeutic doses.
• Pediatric use: Safety and effectiveness in pediatric patients below the age of 4 years have not been established.

SERIOUS ADVERSE EVENTS:

• Sudden withdrawal of Gablofen can result in serious complications that include high fever, confusion, muscle stiffness, multiple organ-system failure, and death. Inform patients that early symptoms of Gablofen withdrawal may include increased spasticity, itching, and tingling of extremities. If Gablofen withdrawal or a pump malfunction is suspected, patients should be brought immediately to a hospital for assessment and treatment.
• Gablofen overdose may occur suddenly or insidiously, and that symptoms may include confusion, drowsiness, lightheadedness, dizziness, slow or shallow breathing, seizures, loss of muscle tone, loss of consciousness, and coma.
• Other serious adverse events may include: potential development of intrathecal mass formation, drainage, infection, meningitis, unmanageable trunk control, CSF leakage, coma and death.

COMMON ADVERSE EVENTS:

• The most common adverse reactions in patients with spasticity of spinal origin were hypotonia (25.3%) somnolence (20.9%), dizziness, nausea/vomiting, hypotension, headache, and convulsions.
• The most common adverse reactions in patients with spasticity of cerebral origin were hypotonia (34.7%), somnolence (18.7%), headache (10.7%) agitation, constipation, leukocytosis, chills, and urinary retention.
• Other common adverse events may include hypoventilation, hypertonia, paresthesia, increased salivation, back pain, pruritus, diarrhea, peripheral edema, asthenia, pain, confusion, speech disorder, amblyopia, accidental injury and dry mouth.

For Full Prescribing Information about Gablofen, click here: http://www.gablofen.com/downloads/Gablofen_Prescribing_Information.pdf

Lioresal is a registered trademark of Medtronic, Inc. ITB Therapy ^SM is a service mark of Medtronic Inc.

About Gablofen

Gablofen is indicated for use in the management of severe spasticity of cerebral or spinal origin. Approved by the FDA in late 2010, Gablofen is a branded, AP-rated alternative for Lioresal ^® Intrathecal (baclofen injection) and is listed in the FDA Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations.

About Covidien

Covidien is a leading global healthcare products company that creates innovative medical solutions for better patient outcomes and delivers value through clinical leadership and excellence. Covidien manufactures, distributes and services a diverse range of industry-leading product lines in three segments: Medical Devices, Pharmaceuticals and Medical Supplies. With 2012 revenue of $11.9 billion, Covidien has 43,000 employees worldwide in 70 countries, and its products are sold in over 140 countries. Please visit www.covidien.com to learn more about our business.

Mallinckrodt, the Pharmaceuticals business of Covidien, is a vertically integrated leader in providing products used in diagnostic procedures and in the treatment of pain and related conditions. The company is the largest US supplier, by prescription, of opioid pain medications and a leading manufacturer of active pharmaceutical ingredients. It is also the largest US supplier of the medical isotope technetium-99m and an industry leader in radiopharmaceuticals and contrast media and delivery systems. Sales in 2012 were $2.0 billion. Please visit http://www.mallinckrodt.com to learn more about our business.

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