Regulatory Focus™ > News Articles > New Brain Hemorrhage Treatment Intended as Improvement Over Existing Risky One

New Brain Hemorrhage Treatment Intended as Improvement Over Existing Risky One

Posted 15 May 2013 | By Alexander Gaffney, RAC

Regulators with the US Food and Drug Administration (FDA) announced on Tuesday the approval of Arbor Pharmaceuticals' drug Nymalize (nimodipine), a drug intended to treat brain hemorrhaging in patients.

FDA's 14 May 2013 statement explained that the agency has received reports over the years regarding "serious and sometimes fatal consequences" associated with using intravenous (IV) injections of nimodipine capsules, including death, cardiac arrest and severe decreases in blood pressure. As a result, the capsule version of the drug has a black box warning and FDA has sent out warnings to healthcare professionals warning them about the risks associated with the drug's use.

But now practitioners and patients may be able to put some of those risks behind them, with regulators announcing that the drug's new oral solution formulation "may help to reduce medication errors."

The new formulation avoids the use of IVs or needles, which Russell Katz, director of FDA's Division of Neurology Products, said was what "caused past medication errors."

The potential to cut down on serious adverse events led FDA to fast-track the application and accept it into its priority review program. Both are intended to expedite the drug's approval by increasing the staff resources available to the product.

In a statement, Arbor said it would further attempt to cut down on errors by packaging each Nymalize unit with an oral syringe in the hopes of preventing it from accidentally being administered via an IV. The drug is the company's first approval new drug application (NDA).

Regulators said the drug's most common side effect is decreased blood pressure, necessitating careful monitoring during treatment.

Read FDA's approval letter here.

Read FDA's approval letter to Arbor here.

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