June 12, 2015

AbbVie to Present Data from Studies of DUOPA® (carbidopa and levodopa) Enteral Suspension in Advanced Parkinson's Disease During the International Congress of Parkinson's Disease and Movement Disorders

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- AbbVie's commitment to advanced Parkinson's disease showcased with seven accepted abstracts

NORTH CHICAGO, Ill., June 12, 2015 /PRNewswire/ -- AbbVie (NYSE: ABBV), a global biopharmaceutical company, today announced it will present data from studies of DUOPA® (carbidopa and levodopa) enteral suspension in patients with advanced Parkinson's disease during the 19th International Congress of Parkinson's Disease and Movement Disorders in San Diego.

"Our continued study of advanced Parkinson's disease demonstrates AbbVie's dedication to make a remarkable impact for patients affected by this devastating disease," said Michael Robinson, M.D., vice president, medical affairs, AbbVie. "AbbVie is committed to ongoing research in this important area of medicine."

Presentations of AbbVie's studies of DUOPA include:

  • Effects of levodopa-carbidopa intestinal gel on non-motor symptoms and safety of outpatient titration: a new phase 3 study in patients with advanced Parkinson's disease; Standaert, DG, et al.; Poster Presentation #327; Monday, June 15, 2015; 12:30-2 p.m. PT
  • Efficacy and Safety of Levodopa-Carbidopa Intestinal Gel in Patients with Less than 10 Years of Parkinson's Disease – Interim Results from the GLORIA Long-term Registry; Antonini, A, et al.; Poster Presentation #175; Monday, June 15, 2015; 12:30-2 p.m. PT
  • Global Long-term Registry on Efficacy and Safety of Levodopa-Carbidopa Intestinal Gel in Patients with Advanced Parkinson's Disease in Routine Care (GLORIA) – Interim Results in a Subgroup of Patients with Dyskinesia at Baseline; Poewe, W, et al.; Poster Presentation #295; Monday, June 15, 2015; 12:30-2 p.m. PT
  • Interim results of outpatient levodopa-carbidopa intestinal gel titration in patients with advanced Parkinson's disease; Rodriguez, R, et al.; Poster Presentation #301; Monday, June 15, 2015; 12:30-2 p.m. PT
  • Role of clinical nurse educators (CNEs) in levodopa-carbidopa intestinal gel (LCIG) clinical studies in Parkinson's disease (PD); Olson, E, et al.; Poster Presentation #282; Monday, June 15, 2015; 12:30-2 p.m. PT
  • Updated long-term safety from ongoing phase 3 trials of levodopa-carbidopa intestinal gel in patients with advanced Parkinson's disease; Rodriguez, R, et al.; Poster Presentation #302; Monday, June 15, 2015; 12:30-2 p.m. PT; Guided Poster Tour #302; Wednesday, June 17, 2015; 12-1:30 p.m. PT
  • Effect of levodopa-carbidopa intestinal gel on resting tremor in patients with advanced Parkinson's disease; Fernandez, H, et al.; Poster Presentation #218; Monday, June 15, 2015; 12:30-2 p.m. PT

Levodopa-carbidopa intestinal gel is marketed by AbbVie as DUODOPA® (levodopa-carbidopa intestinal gel) outside the United States.

About DUOPA® (carbidopa and levodopa) enteral suspension

DUOPA (carbidopa and levodopa) enteral suspension is indicated for the treatment of motor  fluctuations in patients with advanced Parkinson's disease.

Important Safety Information

DUOPA is contraindicated in patients who are currently taking or have taken (within 2 weeks) a nonselective monoamine oxidase (MAO) inhibitor, as concurrent use can cause hypertension. A Percutaneous Endoscopic Gastrostomy with Jejunal Extension (PEG-J) is contraindicated with lack of transillumination/positive needle aspiration test; intestinal obstruction; sepsis; peritonitis; serious coagulation disorders; ascites; and neoplastic, inflammatory, and infiltrative diseases of the gastric and abdominal walls.

Because DUOPA is administered using a PEG-J or naso-jejunal tube, gastrointestinal complications can occur, including bezoar; ileus; implant site erosion/ulcer; intestinal hemorrhage, ischemia, obstruction, or perforation; pancreatitis; peritonitis; pneumoperitoneum; and wound infection, any of which may require surgery or be fatal. Instruct patients to immediately report abdominal pain, prolonged constipation, nausea, vomiting, fever, or melanotic stool.

Patients treated with levodopa (a component of DUOPA) have reported falling asleep while engaged in activities of daily living, including the operation of motor vehicles, which sometimes resulted in accidents. Although many of these patients reported somnolence while on levodopa, some perceived that they had no warning signs (sleep attack), such as excessive drowsiness, and believed they were alert immediately prior to the event. For this reason, prescribers should reassess patients for drowsiness or sleepiness in DUOPA-treated patients, especially since some of the events occur well after the start of treatment. Advise patients about the potential to develop drowsiness with DUOPA and ask about factors that may increase risk of somnolence. Consider discontinuing DUOPA in patients who report significant daytime sleepiness or episodes of falling asleep during activities that require active participation. For these patients, if a decision is made to continue DUOPA, advise them to avoid driving and other potentially dangerous activities that might result in harm if the patients become somnolent.

Monitor patients for orthostatic hypotension, especially after starting DUOPA or increasing the dose.

There is an increased risk for hallucinations, psychosis, and confusion in patients taking DUOPA. Hallucinations associated with levodopa may present shortly after the initiation of therapy and may be responsive to dose reduction of levodopa. Patients with a major psychotic disorder should not be treated with DUOPA.

Patients may experience intense urges while on DUOPA. Because patients may not recognize these behaviors as abnormal, it is important for prescribers to ask patients or their caregivers specifically about the development of new or increased gambling urges, sexual urges, uncontrolled spending, binge or compulsive eating, or other urges while on DUOPA. Consider reducing the dose or discontinuing DUOPA if a patient develops such urges.

Depression has been reported in patients treated with DUOPA. Monitor patients for depression and concomitant suicidal tendencies.

Withdrawal-emergent hyperpyrexia and confusion, a symptom complex that resembles neuroleptic malignant syndrome (characterized by elevated temperature, muscular rigidity, altered consciousness, and autonomic instability), with no other obvious etiology, has been reported in association with rapid dose reduction, withdrawal, or change in dopaminergic therapy. Avoid sudden discontinuation or rapid dose reduction of DUOPA.

DUOPA may cause or exacerbate dyskinesias, which may require a dose reduction of DUOPA or other Parkinson's disease medications.

Generalized polyneuropathy has been reported in patients receiving DUOPA. Assess patients for the signs and symptoms of peripheral neuropathy before and periodically after starting DUOPA, especially patients with pre-existing neuropathy, patients taking medications, or those who have medical conditions associated with neuropathy.

Myocardial infarction and arrhythmia were reported in patients taking carbidopa-levodopa. Ask patients about symptoms of ischemic heart disease and arrhythmia, especially those with a history of myocardial infarction or cardiac arrhythmias.

Parkinson's disease patients have a higher risk of developing melanoma than the general population and should be monitored periodically for melanoma.

DUOPA may increase the risk for elevated blood urea nitrogen (BUN) and creatine phosphokinase (CPK). Patients taking levodopa may have increased levels of catecholamines and their metabolites in plasma and urine, giving false positive results that suggest the diagnosis of pheochromocytoma.

Monitor patients with glaucoma after starting DUOPA, as it may cause increased intraocular pressure.

Drug Interactions: Monitor patients taking selective MAO-B inhibitors and carbidopa-levodopa for orthostatic hypotension. Concurrent administration with antihypertensives may result in postural hypotension, necessitating a dose reduction of the antihypertensive. Co-administration with dopamine D2 antagonists, isoniazid, or iron salts may reduce effectiveness of DUOPA.

The most common adverse events for DUOPA, with an incidence at least 7% greater than oral carbidopa-levodopa immediate release (CLIR), were (DUOPA vs. CLIR): complication of device insertion (57% vs 44%), nausea (30% vs 21%), depression (11% vs 3%), peripheral edema (8% vs 0%), hypertension (8% vs 0%), upper respiratory tract infection (8% vs 0%), oropharyngeal pain (8% vs 0%), atelectasis (8% vs 0%), and incision site erythema (19% vs 12%).

Full Prescribing Information, including the Medication Guide can be found at www.rxabbvie.com.

About AbbVie

AbbVie is a global, research-based biopharmaceutical company formed in 2013 following separation from Abbott Laboratories. The company's mission is to use its expertise, dedicated people and unique approach to innovation to develop and market advanced therapies that address some of the world's most complex and serious diseases. Together with its wholly-owned subsidiary, Pharmacyclics, AbbVie employs more than 28,000 people worldwide and markets medicines in more than 170 countries. For further information on the company and its people, portfolio and commitments, please visit www.abbvie.com. Follow @abbvie on Twitter or view careers on our Facebook or LinkedIn page.

 

SOURCE AbbVie Inc.

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