Impel NeuroPharma enters migraine market with FDA nod for nasal spray (updated)

IPI Legacy Liquidation Co

03/09/2021 14:11

(Adds background, quote)
    Sept 3 (Reuters) - Impel NeuroPharma Inc  IMPL.O  said on
Friday the U.S. health regulator had approved its nasal spray to
treat migraine, marking the drug developer's entry into a market
crowded with oral and intravenous medications.
  Shares of the company, which made its Nasdaq debut in April,
rose about 21% to $27.98 in morning trade after having touched a
record peak earlier in the session. 
    Impel said its drug, Trudhesa, can be self-administered to
the bloodstream by being sprayed in the upper part of the nasal
canal. 
    In a late-stage trial, two-thirds of 360 patients with
migraine had pain relief two hours after being treated with
Trudhesa, Impel said.
    The treatment was formulated using dihydroergotamine, a
fungi-produced compound that tightens blood vessels in the brain
and also forms the basis for many triptans, a class of drugs
commonly prescribed for treating acute migraine and cluster
headaches.
    The company said it plans to commercially launch Trudhesa in
early October, hoping it stands out from rival treatments
including Biohaven Pharmaceutical's  BHVN.N  Nurtec ODT and
AbbVie Inc's  ABBV.N  Ubrelvy, which are administered orally.
    Historically, there have not been enough effective migraine
treatments that are not oral medicines, which cause challenges
due to symptoms such as nausea and vomiting attached to the
condition, said Kevin Lenaburg, executive director of the
Coalition for Headache and Migraine Patients.
    The FDA, however, has attached a strict warning to Impel's
therapy, saying it carries risks of potential impaired blood
supply to the tissues when used in combination with certain
enzyme inhibitors used in steroids.
    Around 39 million Americans and 1 billion people worldwide
suffer from migraines, according to the Migraine Research
Foundation.
    Amneal Pharmaceuticals Inc  AMRX.N  is also developing a
migraine therapy, based on the same compound used by Impel,
which can be administered by self-injection.

 (Reporting by Mrinalika Roy and Amruta Khandekar in Bengaluru;
Editing by Ramakrishnan M.)