Sunovion Announces U.S. FDA Approval of KYNMOBI™ (apomorphine hydrochloride) Sublingual Film for the Treatment of Parkinson’s Disease

Sunovion Pharmaceuticals Inc. (Sunovion) announced today that the U.S. Food and Drug Administration (FDA) has approved KYNMOBI™ (apomorphine HCI) sublingual film (APL-130277) for the acute, intermittent treatment of OFF episodes in patients with Parkinson’s disease (PD). OFF episodes are the re-emergence or worsening of PD symptoms otherwise controlled with oral levodopa/carbidopa. They may be characterized, in part, by tremor, stiffness, slowed movement or other symptoms. These disruptive episodes can occur in the morning upon waking and throughout the day. KYNMOBI dissolves under the tongue to help people with PD improve their OFF symptoms as needed.

INDICATIONS AND USAGE

KYNMOBI is indicated for the acute, intermittent treatment of “off” episodes in patients with Parkinson’s disease (PD).

DOSAGE FORMS AND STRENGTHS

KYNMOBI sublingual film is a blue to green rectangular film with a white printed number identifying the strength (e.g., “10” is 10 mg). KYNMOBI comes in dosage strengths of 10 mg, 15 mg, 20 mg, 25 mg, and 30 mg. Each sublingual film is individually packaged in a sealed foil pouch.

WARNINGS AND PRECAUTIONS

• Nausea and vomiting may occur
  
• Falling asleep during activities of daily living and daytime somnolence may occur, discontinue KYNMOBI if occurs
• Syncope and hypotension/orthostatic hypotension may occur, monitor blood pressure
• Oral mucosal irritation may occur, which may require pausing ordiscontinuing treatment
• Falls may occur, or increase
  
• May cause hallucinations and psychotic-like behavior
  
• May cause impulse control and impulsive behaviors; consider dose reduction or discontinuing KYNMOBI if occurs
  
• Withdrawal-emergent hyperpyrexia and confusion may occur with rapid dose reduction or withdrawal.
  
• May prolong QTc and cause torsades de pointes or sudden death; consider risk factors prior to initiation.

ADVERSE REACTIONS

Most common adverse reactions (incidence at least 10% in patients treated with KYNMOBI and with an incidence greater than placebo) were nausea, oral/pharyngeal soft tissue swelling, oral/pharyngeal soft tissue pain and paraesthesia, dizziness, and somnolence.

DRUG INTERACTIONS

• Concomitant use of antihypertensive medications and vasodilators may increase risk for hypotension, myocardial infarction, falls and injuries
• Dopamine antagonists may diminish the effectiveness of KYNMOBI

Storage and Handling

Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP controlled room temperature]. Keep KYNMOBI in the foil pouch until ready to use.

Referance;

1.https://www.kynmobi.com/Kynmobi-Prescribing-Information.pdf

2.https://news.sunovion.com/press-releases/press-releases-details/2020/Sunovion-Announces-US-FDA-Approval-of-KYNMOBI-apomorphine-hydrochloride-Sublingual-Film-for-the-Treatment-of-Parkinsons-Disease-OFF-Episodes/default.aspx