FDA approves Kynmobi.

  • A new drug Kynmobi (apomorphine hydrochloride) sublingual film is approved by FDA (Food and Drug Administration) for acute, intermittent treatment of OFF episodes in patients with Parkinson’s Disease.
  • Parkinson’s disease (PD) is neurodegenerative disorder related to deficiency of dopamine. It is characterized by tremor, rigidity and bradykinesia. Levodopa- carbidopa therapy is considered gold standard treatment for PD. OFF episodes are worsening, or reemergence of Parkinson’s Disease symptoms otherwise controlled with oral levodopa/carbidopa.
  • Within the first 4-6 years of diagnosis of PD, up to 60 % of PD patients experience OFF episodes like feeling frozen while trying to walk, having difficulty while getting out of chair or having trouble getting out of bed when effect of their maintenance medicine diminishes. Such episodes significantly disrupt patient’s life.
  • Kynmobi sublingual film is a novel formulation of apomorphine which is a dopamine agonist. It is the first and only sublingual therapy for fast-acting, on-demand method of treatment for OFF episodes associated with Parkinson’s disease.
  • Kynmobi can be used as add on therapy in medication regimen of patients who frequently experience OFF episodes.
  • It is a product of Sunovian Pharmaceuticals Inc.
  • It can be used upto 5 times a day. It dissolves under the tongue.
  • The results of phase III clinical trial show significant improvement in motor symptoms at 30 minutes after dosing. Most frequently observed adverse effects were nausea, dizziness, somnolence and oropharyngeal reactions.
  • It should not be taken with 5HT3 antagonist used to treat nausea. It should not be used if patient is allergic to apomorphine hydrochloride.
  • Kynmobi contains sulfite called sodium metabisulfite. Sulfites can cause severe life-threatening allergy in some people. Patients should inform their doctor if any signs like hives, itching, redness of face, trouble in breathing are seen.
  • Its safety and efficacy in children are not known.

Reference

https://www.drugs.com/newdrugs/fda-approves-kynmobi-apomorphine-hydrochloride-sublingual-film-parkinson-s-off-episodes-5234.html