LAB begins enrollment in phase 2b Fentanyl Taifun trial for pain relief

By E. Janene Geiss

Philadelphia, June 13 - LAB International Inc. announced Tuesday enrollment of the first patients in its Fentanyl Taifun phase 2b clinical trial.

Fentanyl Taifun is a fast-acting Fentanyl formulation delivered using the company's Taifun dry powder inhaler platform, according to a company news release.

The multi-centered, multinational, dose titration, single arm and open-label trial is evaluating the time to significant pain relief with Fentanyl Taifun with successful titration in the treatment of breakthrough cancer pain.

The trial is enrolling 32 cancer patients on maintenance opioid therapy for persistent pain.

The first two patients treated with Fentanyl Taifun have both achieved successful titration, one with 400 g dose and the other with 100 g fentanyl per dose.

For both patients, the selected dose was effective in all five pain episodes treated under the protocol, with the first observed effects within five minutes from administration, officials said.

"Although we have just started the trial, we clearly see that Fentanyl Taifun is providing the expected significant and rapid pain relief," Halvor Jaeger, chief executive officer, said in the release.

The information gathered during the trial will provide important additional information required in the preparation of the upcoming phase 3 study, officials said.

Chronic pain associated with advanced cancer is commonly treated with strong opioid analgesics, such as fentanyl.

Breakthrough pain episodes are sudden and intense flares of pain not masked by long-acting continuous treatment, such as a transdermal patch or a slow-release tablet.

Breakthrough pain episodes are common in cancer patients, often occurring several times a day. The only product currently available for the indication is an oral lozenge that requires 15 to 20 minutes application time.

In contrast, Fentanyl Taifun has been demonstrated to provide instantaneous availability of fentanyl in the blood, within one minute from inhalation, and is therefore providing more rapid pain relief than any existing non-injectable pain medication, officials said.

LAB is a Montreal-based integrated drug development company. LAB Pharma is focused on the growing multi-billion dollar inhalation market.

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