FDA Approves Arynta (lisdexamfetamine) Oral Solution for ADHD and Binge Eating Disorder

In continuation of my update on lisdexamfetamine

Food and Drug Administration (FDA) has approved Azurity Pharmaceuticals' Arynta™ (lisdexamfetamine) oral solution for the treatment of attention deficit hyperactivity disorder (ADHD) in adults and pediatric patients 6 years and older, and moderate to severe binge eating disorder (BED) in adults.

Arynta is the first oral solution formulation of lisdexamfetamine, providing a new treatment option for patients who have difficulty swallowing or have a preference for using a liquid dosage form.

Lisdexamfetamine is also available as oral capsules and chewable tablets under the brand name Vyvanse® and generic formulations.

Key Clinical Information

Efficacy: The effectiveness of Arynta has been established based on adequate and well-controlled studies of oral lisdexamfetamine dimesylate in treating adults and pediatric patients 6 years and older with ADHD, and adults with moderate to severe BED.

Dosing for ADHD: The recommended starting dosage is 30 mg once daily in the morning for both adults and pediatric patients 6 years and older. Dosage may be adjusted in increments of 10 mg or 20 mg at weekly intervals, up to a maximum dosage of 70 mg once daily.

Dosing for BED: The recommended starting dosage for adults is 30 mg once daily in the morning, titrated in increments of 20 mg at weekly intervals, up to a maximum dosage of 70 mg once daily. Treatment should be discontinued if binge eating does not improve.

https://en.wikipedia.org/wiki/Lisdexamfetamine

FDA Approves Arynta (lisdexamfetamine) Oral Solution for ADHD and Binge Eating Disorder

FDA Approves Xromi (hydroxyurea) Oral Solution for Use in Pediatric Patients with Sickle Cell Anemia

The U.S. Food and Drug Administration (FDA) has approved Xromi, an oral solution formulation of hydroxyurea indicated to reduce the frequency of painful crises and reduce the need for blood transfusions in pediatric patients aged 6 months of age to less than 2 years with sickle cell anemia with recurrent moderate to severe painful crises.

Sickle cell anemia is caused by an abnormal version of hemoglobin called hemoglobin S, which leads to sickle-shaped red blood cells that can form painful clumps inside the blood vessels. These painful episodes are called sickle cell crises, and are one of the most common and distressing symptoms of sickle cell disease.

Hydroxyurea has been shown to reduce the frequency of painful episodes associated with sickle cell disease. It is thought to work by increasing levels of hemoglobin F (also called fetal hemoglobin because it is present in newborn babies) to make the red blood cells bigger, rounder, more flexible, and less likely to turn into a sickle shape.

Hydroxyurea was first approved in 1967 in an oral capsule formulation as a cancer treatment and has been used by doctors to treat sickle cell anemia since the 1980s. It was approved by the FDA for treating adults with sickle cell anemia in 1998, and children in 2017.

Xromi is supplied as a strawberry-flavored oral solution containing 100 mg/mL hydroxyurea. The Xromi package contains two dosing oral dosing syringes (a red oral dosing syringe graduated to 3 mL and a white oral dosing syringe graduated to 12 mL) for accurate measurement of the prescribed dose.

FDA Approves Xromi (hydroxyurea) Oral Solution for Use in Pediatric Patients with Sickle Cell Anemia

FDA Approves Norliqva (amlodipine) Oral Solution for Hypertension and Coronary Artery Disease

In continuation of my update on amlodipine besylate

The U.S. Food and Drug Administration has approved Norliqva (amlodipine) oral solution for the treatment of:

• Hypertension in adults and children 6 years and older, to lower blood pressure.
• Coronary artery disease [Chronic Stable Angina, Vasospastic Angina (Prinzmetal’s or Variant Angina) and Angiographically Documented Coronary Artery Disease in patients without heart failure or an ejection fraction <40%.]

• Amlodipine is a widely used long-acting calcium channel blocker first approved by the FDA thirty years ago. It is a peripheral arterial vasodilator that acts directly on vascular smooth muscle to cause a reduction in peripheral vascular resistance and reduction in blood pressure, and is thought to reduce the total peripheral resistance and inhibit coronary spasm to relieve angina.

  Amlodipine is FDA approved under the brand names Norvasc (amlodipine oral tablets) and Katerzia (amlodipine oral suspension), and the oral tablets are also available as generics.

  Norliqva is supplied as a peppermint flavored oral solution containing 1 mg/mL amlodipine as the besylate salt. It is administered once daily.

  Most common adverse reactions to amlodipine include edema, dizziness, flushing and palpitation which occurred in a dose related manner. Other adverse reactions not clearly dose-related but reported with an incidence >1.0% are fatigue and nausea.

https://www.webmd.com/drugs/2/drug-5891/amlodipine-oral/details

https://en.wikipedia.org/wiki/Amlodipine