Anesta Actiq Detailing To 2,500 Specialists To Begin In March

Anesta and marketing partner Abbott will detail Actiq to a "core group" of 2,500 cancer pain management and oncology specialists with experience in opioid use following the Nov. 4 approval of the flavored "lozenge on a handle" product.

Six doses of Actiq ranging from 200 mcg to 1600 mcg will be available in mid-March at a cost of about $6-$15 per unit, Anesta said. The company plans to "aggressively" stock wholesalers and the top 3,300 retail pharmacies that are the highest providers of Schedule II-type opioids for cancer pain.

Abbott will market the breakthrough cancer pain treatment with 20-40 sales reps and a group of clinical nurses to facilitate "teaching and learning in the outpatient environment." Six Anesta "regional medical liaisons" will also work with high prescribers. Labeling specifies that all patients be started on the lowest 200 mcg dose and then be titrated up if necessary.

The oral transmucosal fentanyl is indicated for the management of breakthrough cancer pain in patients with malignancies who are already receiving and who are tolerant to opioid therapy. Actiq is similar to Anesta's Fentanyl Oralet, also marketed by Abbott. Oralet contains different doses of fentanyl and is not packaged to prevent accidental pediatric consumption because it is administered in hospitals.

Approval of Actiq comes six months to the day after Anesta filed a May 4 NDA amendment containing a reanalysis of adverse event and dosing profile data, more information on stability and packaging, and an expanded risk-management plan.

Anesta received a "not approvable" letter in November 1997 for the NDA submitted a year earlier, despite a unanimous advisory committee decision that the benefits of Actiq outweighed the risks to children ("The Pink Sheet, Nov. 24, T&G-11). In response, Anesta conducted additional child perception studies to demonstrate that the drug is not perceived as "candy."

In a 130-patient pivotal trial, Actiq provided greater pain relief than placebo at 15, 30, 45 and 60 minutes, averaging 1.98 points on a four-point pain relief scale compared to 1.19 for placebo. In a follow-up phase, 15% of Actiq patient chose retreatment compared with 34% of placebo patients.

The Actiq comprehensive risk management program will educate physicians, nurses, patients and caregivers about the potential risk of accidental ingestion by children, improper patient selection and diversion or abuse.

"The surveillance requirement that we have with FDA is to, on a quarterly basis, review where the product is being used, where the product is being prescribed, and try to assess the appropriateness of that prescribing," Anesta CEO Thomas King said Nov. 5.

"We are made aware through the surveillance program if a physician is routinely prescribing the product in an inappropriate way, then we will remind them what the indications are and what the proper patient selection is for the product," King said. Abbott is organizing a "SWAT team" to investigate instances of Actiq misuse ("The Pink Sheet" Sept. 29, 1997, T&G-3).

A patient-oriented "welcome kit" with educational materials, instructional videotape, phone stickers with emergency instructions and a designated poison control toll-free phone number will accompany each new prescription. Multiple "keep away from children" warnings are printed on the leaflet, the on the shelf box and on each individual, child resistant-wrapped unit.

Actiq is contraindicated in the management of acute or postoperative pain and should not be prescribed for opioid non-tolerant patients, labeling states. The most common adverse events include somnolence, nausea, vomiting and dizziness.

Actiq will be packaged in 24-unit boxes. However, because labeling specifies that all patients should be started at the lowest dose and then titrated up, pharmacies are instructed to only dispense six units at a time until "successful dose" is reached. Abbott is creating a pharmacy software program that will automatically produce a warning "check for other opioid prescriptions" message when pharmacists enter the Actiq name.

Anesta plans Phase IV studies in pediatric and AIDS patient populations. The company will also continue its long-term safety study, which includes "a couple patients that have taken the product for over 900 days." Anesta is also planning to study Actiq in cancer patients with moderate to severe oral mucositis, and is sponsoring a study comparing morphine sulfate immediate release capsules to Actiq.