FDA Approvals: Lumigan, Cesamet, Omnitrope

Yael Waknine

July 14, 2006

July 14, 2006 — The US Food and Drug Administration (FDA) has approved an expanded indication for bimatoprost 0.03% ophthalmic solution, allowing its first-line use for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension; nabilone 1-mg capsules for the second-line treatment of nausea and vomiting associated with cancer chemotherapy; and a recombinant DNA follow-on formulation of somatropin for the treatment of growth hormone deficiency disorders in children and adults.


Bimatoprost Ophthalmic Solution (Lumigan) for First-Line Reduction of Elevated IOP

On June 22, the FDA approved an expanded indication for bimatoprost 0.03% ophthalmic solution ( Lumigan, made by Allergan, Inc), allowing its first-line use for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.

The product was previously approved for use in patients who were intolerant or insufficiently responsive to other IOP-lowering medications.


Cannabinoid Drug Nabilone (Cesamet) for Chemotherapy-Related Nausea/Vomiting

On May 15, the FDA approved nabilone 1-mg capsules ( Cesamet, made by Valeant Pharmaceuticals International) for the treatment of nausea and vomiting associated with cancer chemotherapy in patients who have failed to respond adequately to conventional antiemetic treatments.

This restriction is required due to the substantial risk for disturbing psychotomimetic reactions in patients receiving the synthetic cannabinoid; these events have not been observed with other antiemetic agents. These central nervous system effects may manifest as dizziness, drowsiness, euphoria, ataxia, anxiety, disorientation, depression, hallucinations, and psychosis, which can persist for 48 to 72 hours following therapy discontinuation.

Patients should be advised that concomitant use of alcohol, sedatives, hypnotics, or other psychoactive substances can potentiate these effects. They should also be warned against driving, operating machinery, and engaging in hazardous activity during treatment, according to the FDA.

Because of individual variations in response and tolerance, patients receiving nabilone should remain under the supervision of a responsible adult, particularly during initiation of therapy and during dose adjustments.

The FDA notes that nabilone is a class 2 controlled substance with a high potential for abuse. The number of capsules dispensed should therefore be limited to that required for a single cycle of chemotherapy (a few days).

As with all controlled drugs, prescribers should monitor patients receiving nabilone for signs of excessive use, abuse, and misuse. Patients who may be at increased risk for substance abuse include those with a personal or family history of substance abuse (including drug or alcohol abuse) or mental illness.

Nabilone can also elevate supine and standing heart rates and cause postural hypotension, and it should be used with caution in elderly patients and those with hypertension or heart disease. Its effects on QT prolongation have not been determined. Caution is also advised when administering nabilone to pregnant patients, nursing mothers, or pediatric patients due to lack of relevant safety data for these populations.

Nabilone has a longer duration of action than other antiemetics; although the recommended dose is 1 or 2 mg twice daily, once-daily dosing is sufficient for many patients. The initial dose should be given 1 to 3 hours prior to administration of the chemotherapeutic agent.

To reduce the risk for adverse events, the FDA recommends use of a lower starting dose that can be increased as necessary to a maximum of 6 mg/day administered in 3 divided doses. Nabilone may be given 2 or 3 times daily during the entire course of each chemotherapy cycle and, if needed, for 48 hours after the last dose of each cycle.

Nabilone capsules were previously approved for use in Canada.


Follow-On Somatropin Product (Omnitrope) for Growth Hormone–Deficient Children and Adults

On May 30, the FDA approved a recombinant DNA follow-on formulation of somatropin ( Omnitrope 1.5- and 5.8-mg vials, made by Sandoz, a Novartis AG company) for use in the long-term treatment of pediatric patients with growth failure due to inadequate secretion of endogenous growth hormone (GH), and as long-term replacement therapy for adults with GH deficiency of either childhood- or adult-onset etiology.

According to the FDA, the drug's designation as a follow-on product indicates that its similarity to previously approved human growth hormones allowed consideration of their safety and efficacy data as part of the approval process. However, Omnitrope is not rated as therapeutically equivalent to (and therefore substitutable for) any of these other products.

Omnitrope was previously approved as a "biosimilar" by the Australian Therapeutic Goods Administration and European Commission in October 2004 and April 2006, respectively, with additional indications for Prader-Willi syndrome and the treatment of infants born small for gestational age who fail to manifest catch-up growth by age 2 years.

Reviewed by Gary D. Vogin, MD

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