FDA Approves Palladone, Stent System, SonoPrep, First-Time Generics

Yael Waknine

September 30, 2004

Sept. 30, 2004 — The U.S. Food and Drug Administration (FDA) has approved hydromorphone HCl extended-release capsules for long-term, persistent moderate to severe pain; a stent system for use in small-vessel coronary artery disease; an ultrasonic device that increases skin permeability to allow rapid topical anesthesia; and first-time generic formulations for dexrazoxane HCl, 2.5 mg bromocriptine mesylate, 330 mg levocarnitine, and mesalamine rectal suspension (enema).

Hydromorphone (Palladone) for Persistent Moderate to Severe Pain

On Sept. 24, the FDA approved hydromorphone HCl extended-release capsules (Palladone, made by Purdue Pharma L.P.), indicated in the management of persistent moderate to severe pain in patients requiring continuous, 24-hour analgesia with a high potency opioid for an extended period of time (weeks to months) or longer. The conditions causing pain may be cancerous or noncancerous in nature.

The long-acting formulation is intended for use in patients already receiving opioid therapy who have demonstrated a tolerance and who require a minimum total daily dose equivalent to 12 mg of oral hydromorphone. Patients considered opioid tolerant are those taking at least 60 mg per day oral morphine, 30 mg per day oral oxycodone, 8 mg per day oral hydromorphone, or an equianalgesic dose of another opioid for a minimum of one week.

Hydromorphone extended-release capsules are not intended for use as a first opioid product prescribed for a patient, or in patients requiring short-term analgesia. They are contraindicated for use on an as needed (prn) basis.

Use in nonopioid tolerant patients or use of an overestimated dose due to inaccurate conversion from other opioids may lead to fatal respiratory depression. Due to the 18-hour elimination half-life, extended treatment and monitoring is required for overdosed patients. Continued monitoring is required after patient improvement due to the possibility of extended effects.

Other adverse effects include nausea, vomiting, dry mouth, dizziness, urinary retention, and constipation.

The FDA has worked with the company in implementing a risk management program to assess the risks of improper dosing, indication, or patient selection; the risk posed by accidental pediatric exposure to the drug; and the risk posed by abuse or diversion of hydromorphone extended-release capsules.

The FDA advises that patients be assessed for clinical risks of opioid abuse prior to therapy, including the risks associated with personal or family history of substance abuse or mental illness. All patients should be routinely monitored for signs of misuse, abuse, and addictions; those at increased risk of abuse should be monitored intensively.

Stent System (Multi-Link Mini Vision) for Small-Vessel Coronary Artery Disease

On Sept. 16, the FDA approved a coronary stent system (Multi-Link Mini Vision, made by Guidant Corp.), indicated for use in treating coronary artery disease in patients with small vessels at risk of sudden closure.

The stent is made of cobalt chromium, allowing a thinner strut design for flexibility and deliverability to lesions in vessels with diameters of less than 2.5 mm.

The stent system was approved for use in the European Union in August.

Ultrasonic Device (SonoPrep) With Lidocaine Provides Rapid Topical Anesthesia

On Aug. 18, the FDA approved an ultrasonic skin-permeation device and procedure tray (SonoPrep, made by Sontra Medical Corp.) for use with topical lidocaine when rapid skin anesthesia is warranted, such as prior to insertion of intravenous needles and catheters.

The approval was based on the results of three clinical trials involving 500 patients, showing that pretreatment with the device reduced the time to skin anesthesia with 4% lidocaine from 60 minutes to five minutes.

The device increases skin permeability to drugs in a 15-second application of low-frequency ultrasound to the patient's skin that creates imperceptible, reversible microchannels through the stratum corneum. The increased permeability results in an accelerated onset of action for transdermal drugs.

According to a company news release, the ultrasound technology is also being investigated in the transdermal delivery of pain drugs, vaccines, and protein biopharmaceuticals in addition to continuous noninvasive glucose monitoring.

The device was first approved by the FDA in February 2004 for use in electrophysiology applications.

First Time Generics: Dexrazoxane (Zinecard), 2.5 mg Bromocriptine (Parlodel), 330 mg Levocarnitine (Carnitor), and Mesalamine Rectal Suspension (Rowasa Rectal Enema)

On Sept. 28, the FDA approved the first-time generic dexrazoxane HCl injection (made by Bedford Labs; equivalent to Zinecard, made by Pharmacia & Upjohn), which is indicated for use as a cardioprotective agent in conjunction with doxorubicin.

On Sept. 24, the FDA approved the first-time generic 2.5 mg bromocriptine mesylate tablets (made by Lek Pharmaceuticals; equivalent to Parlodel, made by Aventis), which is indicated in the treatment of dysfunctions associated with hyperprolactinemia, infertility, or hypogonadism, and signs and symptoms of Parkinson's disease.

On Sept. 20, the FDA approved the first-time generic 330 mg levocarnitine tablets (made by Core Pharmaceuticals; equivalent to Carnitor, made by Sigma Tau Pharmaceuticals, Inc.), which is indicated in the treatment of primary systemic carnitine deficiency.

On Sept. 17, the FDA approved the first-time generic mesalamine rectal suspension enema (made by Clay Park; equivalent to Rowasa Rectal enema, made by Solvay), which indicated in the treatment of mild to moderate ulcerative colitis.

Reviewed by Gary D. Vogin, MD

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