FDA approves new ready-to-use liquid treatment for LGS, other seizures
New formulation is expected to be commercially available by the end of 2026
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The FDA has approved Lamlique, a ready-to-use oral liquid formulation of lamotrigine, for approved epilepsy and bipolar I maintenance indications. (Image by iStock)
The U.S. Food and Drug Administration (FDA) has approved Lamlique, a ready-to-use oral liquid formulation of the antiseizure medication lamotrigine.
Like other immediate-release lamotrigine products, Lamlique is indicated for use as an add-on treatment to help control seizures in people ages 2 and older who have Lennox-Gastaut syndrome (LGS) or certain other forms of epilepsy. It also may be used alone in certain patients ages 16 and older with partial-onset seizures who are switching from certain other antiseizure medications. Lamlique and other immediate-release lamotrigine products are also approved for maintenance treatment of bipolar I disorder in adults.
New liquid formulation comes in 2 strengths
Lamlique will be marketed by Azurity Pharmaceuticals. According to a press release from the company, the therapy is available in two dose strengths (5 mg/mL and 25 mg/mL), and it does not require compounding or refrigeration. Azurity said that this new formulation of lamotrigine can support individuals whose treatment needs evolve over time, such as patients who may benefit from dosing flexibility or an alternative to solid oral dosage forms.
The newly approved formulation is expected to be commercially available by the end of 2026, according to Azurity.
“A medicine can be well established and still have opportunities to work better in the realities of patients’ lives,” said Ronald Scarboro, Azurity’s CEO. “Lamlique is a good example of how we think about innovation at Azurity: understand where treatment can be made easier, and then use our capabilities to make it meaningfully better.”
“By providing a ready-to-use oral liquid formulation of lamotrigine, we are expanding the options available to patients with epilepsy and those who care for them,” Scarboro said. “That is what redefining medicine for the real world means to us.”
LGS is a rare form of epilepsy marked by developmental problems and seizures. Lamotrigine is an antiseizure medication that works by modulating nerve cell activity, helping reduce the excessive nerve activity that characterizes seizures. Two other branded lamotrigine products — Lamictal, marketed by GSK in several tablet forms, and Subvenite, a ready-to-use oral liquid suspension marketed by OWP Pharmaceuticals — have also been FDA-approved. Generic versions of lamotrigine are also available.
Lamotrigine products carry a boxed warning — the FDA’s most stringent safety precaution — noting that the medication can cause serious skin rashes that may, in some cases, be life-threatening.
