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Zuplenz (ondansetron oral soluble film)

The following drug information is obtained from various newswires, published medical journal articles, and medical conference presentations.

Company: Strativa Pharmaceuticals
Approval Status: Approved July 2010
Treatment Area: post-operative, chemotherapy and radiotherapy induced nausea and vomiting

General Information

Zuplenz is an oral soluble film formulation of the FDA approved drug ondansetron, a selective 5-HT3 receptor antagonist. Zuplenz uses proprietary PharmFilm oral soluble film technology from MonoSol Rx to rapidly dissolve on the tongue without the need for water, which can cause additional discomfort for patients suffering from nausea and vomiting.

Zuplenz is specifically indicated for the prevention of nausea and vomiting associated with the following: highly emetogenic cancer chemotherapy, initial and repeat courses of moderately emetogenic cancer chemotherapy, radiotherapy in patients receiving total body irradiation, single high-dose fraction to abdomen, or daily fractions to the abdomen and post-operation.

The recommended dosing of Zuplenz oral soluble film is as follows:
Prevention of nausea and vomiting associated with highly emetogenic cancer chemotherapy:
The adult oral dosage is 24 mg given successively as three 8 mg films 30 minutes before the start of chemotherapy.
Prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy:
Adults and pediatric patients 12 years of age and older: One 8 mg film 30 minutes before chemotherapy followed by an 8 mg dose 8 hours later. Administer one 8 mg film twice a day (every 12 hours) for 1 to 2 days after completion of chemotherapy.
Pediatric patients 4 through 11 years of age: One 4 mg film three times a day. Administer the first dose 30 minutes before chemotherapy, with subsequent doses 4 and 8 hours later. Administer one 4 mg film three times a day (every 8 hours) for 1 to 2 days after completion of chemotherapy.
Prevention of nausea and vomiting associated with radiotherapy:
The adult dosage is one 8 mg film three times a day.
Postoperative nausea and vomiting:
The adult dose is 16 mg given successively as two 8 mg films 1 hour before anesthesia.

Clinical Results

FDA Approval
The FDA approval of Zuplenz oral film was based on the following studies evaluating odansetron tablets, as well as a bioequivalence study.
Bioequivalence Study
A clinical study compared the bioequivalence of Zuplenz 8 mg to Zofran ODT (orally dissolving tablet) 8 mg. The pharmacokinetic results of these studies demonstrated that a single dose of Zuplenz, taken with or without water and under fed and fasting conditions, was comparable to Zofran ODT.
Chemotherapy-Induced Nausea and Vomiting
Highly Emetogenic Chemotherapy
Two randomized, double-blind, monotherapy trials evaluated a single 24 mg ondansetron HCl tablet. The first trial enrolled 357 adult cancer patients receiving chemotherapy regimens containing cisplatin >50 mg/m2. The subjects received oral doses of ondansetron 24 mg once a day, 8 mg twice a day, and 32 mg once a day. A total of 66% of patients in the ondansetron 24 mg once-a-day group, 55% in the ondansetron 8 mg twice-a-day group, and 55% in the ondansetron 32 mg once-a-day group completed the 24hour study period with no emetic episodes and no rescue antiemetic medications, the primary endpoint of efficacy. Each of the three treatment groups was shown to be statistically significantly superior to a historical placebo control. The second trial was similar in design and confirmed the results.
Moderately Emetogenic Chemotherapy
In one double-blind US study, 67 patients received ondansetron HCl tablets 8 mg administered twice a day were significantly more effective than placebo in preventing vomiting induced by cyclophosphamide-based chemotherapy containing doxorubicin. Treatment response is based on the total number of emetic episodes over the 3-day study period. Zero emetic episodes were reported by 61% of the odansetron arm versus 6% of the placebo arm. In a second double-blind US study in 336 patients, ondansetron HCl tablets 8 mg administered twice a day were as effective as ondansetron HCl tablets 8 mg administered 3 times a day in preventing nausea and vomiting induced by cyclophosphamide-based chemotherapy containing either methotrexate or doxorubicin.
Pediatrics
Three open-label, uncontrolled, foreign trials enrolled 182 pediatric patients 4 to 18 years old with cancer who were given a variety of cisplatin or non-cisplatin regimens. In these trials, the initial dose of ondansetron HCl injection ranged from 0.04 mg/kg to 0.87 mg/kg for a total dose of 2.16 mg to 12 mg. This was followed by the administration of ondansetron HCl tablets ranging from 4 mg to 24 mg daily for 3 days. In these studies, 58% of the 170 evaluable patients had a complete response (no emetic episodes) on day 1. Two studies showed the response rates for patients less than 12 years of age who received ondansetron HCl tablets 4 mg three times daily to be similar to those in patients 12 to 18 years of age who received ondansetron HCl tablets 8 mg three times daily.
Radiation-Induced Nausea and Vomiting
Total Body Irradiation
In a randomized, double-blind study in 20 patients, ondansetron HCl tablets (8 mg given 1.5 hours before each fraction of radiotherapy for 4 days) were significantly more effective than placebo in preventing vomiting induced by total body irradiation.
Single High-Dose Fraction Radiotherapy
In a double-blind trial in 105 patients receiving single high-dose radiotherapy (800 to 1,000 cGy) over an anterior or posterior field size of >80 cm2 to the abdomen, ondansetron was significantly more effective than metoclopramide with respect to complete control of emesis (0 emetic episodes). Patients received the first dose of ondansetron HCl tablets (8 mg) or metoclopramide (10 mg) 1 to 2 hours before radiotherapy. If radiotherapy was given in the morning, 2 additional doses of study treatment were given (1 tablet late afternoon and 1 tablet before bedtime). If radiotherapy was given in the afternoon, patients took only 1 further tablet that day before bedtime. Patients continued the oral medication on a three times daily basis for 3 days.
Daily Fractionated Radiotherapy
A double-blind trial enrolled 135 patients receiving a 1- to 4-week course of fractionated radiotherapy (180 cGy doses) over a field size of >100 cm2 to the abdomen. The subjects received the first dose of ondansetron HCl tablets (8 mg) or prochlorperazine (10 mg) 1 to 2 hours before the first daily radiotherapy fraction, with 2 subsequent doses on a three times a day basis. Patients continued the oral medication on a three times daily basis on each day of radiotherapy. Ondansetron was significantly more effective than prochlorperazine with respect to complete control of emesis (0 emetic episodes).
Postoperative Nausea and Vomiting
Two double-blind studies (1 US study, 1 foreign) enrolled 865 women who received ondansetron 1 hour before the induction of general balanced anesthesia. Ondansetron HCl tablets (16 mg) were significantly more effective than placebo in preventing postoperative nausea and vomiting.

Side Effects

Adverse events associated with the use of odansetron may include, but are not limited to, the following:
chemotherapy-induced nausea and vomiting and radiotherapy-induced nausea and vomiting:

  • Headache
  • Malaise/fatigue
  • Constipation
  • Diarrhea

Postoperative nausea and vomiting
  • Headache
  • Hypoxia
  • Pyrexia
  • Dizziness

Mechanism of Action

Ondansetron is a selective 5-HT3 receptor antagonist.

Additional Information

For additional information regarding post-operative, chemotherapy or radiotherapy induced nausea and vomiting or Zuplenz oral film, please visit the Strativa web page.