Nektar says pain drug gets fast track FDA status

Nektar Therapeutics says FDA gives fast track incentives to chronic pain drug NKTR-181

Associated Press

SAN FRANCISCO (AP) -- Nektar Therapeutics said Thursday that regulators are giving fast track status to an experimental pain drug the company is developing.

The company's drug NKTR-181 is designed to treat moderate to severe chronic pain. Nektar said the drug may be less likely to be abused than other pain medications because it takes effect on the brain slowly. Abuse of opioid pain medications has become a major problem in recent years and companies have been trying to develop drugs that are harder or less attractive to would-be recreational users.

Some of those drugs have time-release technology that can be defeated if the drugs are crushed or dissolved, allowing users to get the entire dose quickly. Companies have dealt with the problem in a variety of ways, including putting the medication in a gel that doesn't dissolve or combining their pain drugs with other chemicals that have uncomfortable side effects. Nektar's drug is designed to take effect gradually no matter what is done to the pill.

The fast-track designation allows Nektar to submit its marketing application to the Food and Drug Administration piece by piece instead of having to file all the paperwork at once. It also allows for more frequent interaction with the agency and a possible priority review.

Nektar said it plans to start a mid-stage trial of NKTR-181 in July. The trial will test the drug's safety and effectiveness in treating chronic pain caused by osteoarthritis of the knee. It is also planning a study that will evaluate the drug's potential for abuse.

The company's other experimental drugs include the constipation treatment naloxegol; etirinotecan, a treatment for breast and ovarian cancer and gastrointestinal cancers; and several pain treatments.

Shares of Nektar Therapeutics rose 26 cents, or 3.8 percent, to $7.08 in morning trading.

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