Palladone, Abilify

Skin & Allergy News,  Dec, 2004  by Elizabeth Mechcatie

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Palladone

(hydromorphone hydrochloride extended release, Purdue Pharma)

An extended-release formulation of the opioid agonist for managing persistent moderate to severe pain in patients requiring around-the-clock analgesia with a high-potency opioid for a prolonged time (generally weeks to months or longer). A schedule II controlled substance.

* Recommended Dosage: Given once every 24 hours; starting close based on previous opioid dose and other factors. Capsules swallowed whole; should not be chewed, crushed, broken, or dissolved; that can increase absorption and possibly cause a fatal overdose, the label states.

* Special Considerations: Only for opioid-tolerant patients on opioid therapy, who require a minimum total daily opiate dose equal to 12 mg of oral hydromorphone. A black box warning includes precautions about the drug's high potential for abuse and the risk of fatal respiratory depression in non-opioid-tolerant patients; contraindicated for use on an as-needed basis.

Approved with a risk management plan aimed at reducing abuse and minimizing diversion of Palladone (a notorious problem with another Purdue Pharma controlled-release opioid agonist, Oxycontin); selecting the proper patients; and avoiding accidental pediatric use. The plan includes education of prescribers, caregivers, and patients; and a program to monitor for abuse and intervene if abuse, misuse, and diversion of the drug are identified. Available in the first half of 2005; will be marketed initially only to health professionals experienced in prescribing opioid analgesics. Not approved for pediatric use.

* Comment: Eliot Cole, M.D., a consultant to the pain service, Kaiser Permanente, Honolulu, and executive director of the American Society for Pain Educators, Montclair, N.J., said standard hydromorphone is dosed every 4 hours for the typical pain patient, so a patient requiring around-the-clock pain management would need 5-6 doses. Daily use of palladone can "maintain the same degree of comfort."

It will be helpful to have an alternative to controlled release morphine, also taken once every 24 hours. "For some individuals, morphine becomes a very toxic medicine," he noted, especially in those with poor kidney function and in women, and large amounts of oral morphine can lead to a confusional state, delirium, and even an increase in pain. Dr. Cole has not done clinical trials for Purdue Pharma, but is on the company's speakers' bureau.

Abilify

(aripiprazole, Bristol-Myers Squibb)

An atypical antipsychotic for the treatment of acute manic or mixed episodes associated with bipolar disorder. Approved for schizophrenia in 2002.

* Recommended Dosage: Starting dose in clinical trials was 30 mg/day; lowered to 15 rag/day based on tolerability in 15% of patients.

* Special Considerations: In 3-week clinical trials, akathisia, constipation, and accidental injury were the only side effects noted in more than 5% of patients on Abilify and were reported at least twice as often as with placebo. Those on Abilify had no increase in weight, blood sugar levels, or lipids, according to BMS. The label carries a class warning that hyperglycemia--sometimes severe and associated with ketoacidosis or hyperosmolar coma or death--has been reported in patients on atypicals. It's unclear whether limited experience with Abilify accounts for the low number of reports of hyperglycemia, the label states.

* Comment: In two 3-week trials of 516 hospitalized patients with bipolar I disorder, experiencing manic or mixed episodes, those taking Abilify had significant reductions in the Young Mania Rating Scale (used to assess manic symptoms) and the Clinical Global Impression--bipolar version scale, compared with placebo patients.

"Aripiprazole is a wonderful addition to our ability to treat both pure manic and mixed episodes,'" said Robert Hirschfeld, M.D., professor and chair of the department of psychiatry and behavioral sciences at the University of Texas Medical Branch at Galveston. "It is extremely calming," he said, but it is less sedating than other atypical antipsychotics approved for bipolar disorder, Zyprexa (olanzapine), Risperdal (risperidone), and Seroquel (quetiapine).

Patients who will especially benefit from Abilify are those with relatively less severe mania who don't require heavy sedation, added Dr. Hirschfeld, who has been a consultant to BMS and to virtually all companies with products for bipolar disorder.

Robert Finn, San Francisco Bureau, contributed to this column.

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