Woburn, MA, Sept. 28, 2026 (GLOBE NEWSWIRE) -- Azurity Pharmaceuticals, a privately held global pharmaceutical company dedicated to redefining medicine for the real world, today announced that the U.S. Food and Drug Administration (FDA) has approved Lamlique™ (lamotrigine) oral suspension, a ready-to-use oral liquid formulation of lamotrigine designed to support individualized epilepsy treatment.
Lamlique is approved as: 1) adjunctive therapy in patients aged 2 years and older for partial-onset seizures, primary generalized tonic-clonic (PGTC) seizures, and generalized seizures of Lennox-Gastaut syndrome; 2) conversion to monotherapy in patients with partial-onset seizures who are receiving treatment with certain other antiepileptic drugs; and 3) maintenance treatment of bipolar I disorder to delay the time to occurrence of mood episodes in adult patients treated for acute mood episodes with standard therapy. For Complete information including the BOXED WARNING, see Important Safety Information and the Prescribing Information.
At Azurity, we believe medicines should work not only in controlled settings, but in the realities of everyday life. Guided by that belief, the company develops innovative dosage forms and formulations that address unmet patient needs and help improve the treatment experience across a broad range of conditions.
Lamlique builds on the established clinical experience of lamotrigine and offers a ready-to-use oral liquid formulation that can support patients whose treatment needs evolve over time, including those who may benefit from dosing flexibility or an alternative to solid oral dosage forms. Lamlique does not require compounding or refrigeration and is available in two strengths, 5 mg/mL and 25 mg/mL.
“A medicine can be well established and still have opportunities to work better in the realities of patients’ lives,” said Ronald Scarboro, Chief Executive Officer of Azurity Pharmaceuticals. “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. That is what redefining medicine for the real world means to us.”
Epilepsy affects approximately 3.4 million people in the United States, including over 450,000 children.1 While lamotrigine remains an established treatment option, for some patients, dosage form and dosing considerations can be important factors in treatment. Lamlique provides a ready-to-use oral liquid formulation of lamotrigine, offering an additional administration option for appropriate patients.
Lamlique is expected to be available by end of year 2026.
LAMLIQUE™ (lamotrigine) Oral Suspension
INDICATIONS
LAMLIQUE is a prescription medicine used:
· together with other medicines to treat certain types of seizures (partial-onset seizures, primary generalized tonic-clonic seizures, generalized seizures of Lennox-Gastaut syndrome) in people aged 2 years and older.
· alone when changing from 1 other medicine used to treat partial-onset seizures in people aged 16 years and older.
· for the long-term treatment of bipolar I disorder to lengthen the time between mood episodes in people who have been treated for mood episodes with other medicine. LAMLIQUE should not be used for acute treatment of manic or mixed mood episodes.
IMPORTANT SAFETY INFORMATION
What is the most important information I should know about LAMLIQUE?
1. LAMLIQUE may cause a serious skin rash that may cause you to be hospitalized or even cause death. A serious skin rash can happen at any time during your treatment with LAMLIQUE, but is more likely to happen within the first 2 to 8 weeks of treatment. Children and teenagers aged between 2 and 17 years have a higher chance of getting this serious skin rash.
The risk of getting a serious skin rash is higher if you:
· take LAMLIQUE while taking valproate [valproic acid or DEPAKOTE (divalproex sodium)].
· take a higher starting dose of LAMLIQUE than your healthcare provider prescribed.
· increase your dose of LAMLIQUE faster than prescribed.
The risk of serious skin reactions may be associated with a variant in genes called HLA-B*1502 in people from Asian origin (mainly of Han Chinese and Thai origin).
Call your healthcare provider right away if you have a skin rash, blistering or peeling of your skin, hives, or painful sores in your mouth or around your eyes.
These symptoms may be the first signs of a serious skin reaction. A healthcare provider should examine you to decide if you should continue taking LAMLIQUE.
2. Other serious reactions, including serious blood problems or liver problems. LAMLIQUE can also cause other types of allergic reactions or serious problems that may affect organs and other parts of your body like your liver or blood cells. Call your healthcare provider right away if you have any of these symptoms: fever; frequent infections; severe muscle pain; swelling of your face, eyes, lips, or tongue; swollen lymph glands; unusual bruising or bleeding, looking pale; weakness, fatigue; yellowing of your skin or the white part of your eyes; trouble walking or seeing; seizures for the first time or happening more often; pain or tenderness in the area towards the top of your stomach (enlarged liver or spleen)
3. LAMLIQUE can cause abnormal heart rhythms, which may be life-threatening. This risk may be increased in people with underlying heart problems. Call your healthcare provider right away if you have a fast, slow, or pounding heartbeat, loss of consciousness (fainting), dizziness, shortness of breath, or chest pain.
4. Like other antiepileptic drugs, LAMLIQUE may cause suicidal thoughts or actions in a very small number of people, about 1 in 500. Call a healthcare provider right away if you have any of these symptoms, especially if they are new, worse, or worry you: thoughts about suicide or dying; suicide attempt; new or worse depression; new or worse anxiety; feeling agitated or restless; panic attacks; trouble sleeping (insomnia); new or worse irritability; acting aggressive, being angry, or violent; acting on dangerous impulses; an extreme increase in activity and talking (mania); other unusual changes in behavior or mood.
Do not stop LAMLIQUE without first talking to a healthcare provider. Stopping LAMLIQUE suddenly can cause serious problems, such as having seizures that do not stop.
5. LAMLIQUE may cause aseptic meningitis, a serious inflammation of the protective membrane that covers the brain and spinal cord. Call your healthcare provider right away if you have any symptoms of headache, fever, nausea, vomiting, stiff neck, rash, unusual sensitivity to light, muscle pains, chills, confusion, or drowsiness.
6. People prescribed LAMLIQUE have sometimes been given the wrong medicine because many medicines have names similar to LAMLIQUE, so always check that you receive LAMLIQUE.
Do not take LAMLIQUE if you have had an allergic reaction to lamotrigine or to any of the inactive ingredients in LAMLIQUE.
Before taking LAMLIQUE, tell your healthcare provider about all of your health conditions, including if you:
· have had a rash or allergic reaction to another medicine to treat seizures.
· know you are carrying the genetic variant, HLA-B*1502.
· have or have had depression, mood problems, or suicidal thoughts or behavior.
· have a history of heart problems or irregular heartbeats or any of your family members have any heart problem, including genetic abnormalities.
· have had aseptic meningitis after taking LAMLIQUE (lamotrigine).
· are taking estrogen-containing products, including oral contraceptives (birth control pills) or other female hormonal medicines (such as hormone replacement therapy). Do not start or stop taking birth control pills or other female hormonal medicine until you have talked with your healthcare provider.
· are pregnant or plan to become pregnant. It is not known if LAMLIQUE may harm your unborn baby.
· are breastfeeding. LAMLIQUE passes into breast milk and may cause side effects in a breastfed baby.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. LAMLIQUE and certain other medicines may interact with each other. This may cause serious side effects.
The most common side effects of LAMLIQUE include dizziness, sleepiness, tremor, back pain, headache, nausea, vomiting, rash, diarrhea, blurred or double vision, tiredness, fever, insomnia, lack of coordination, dry mouth, abdominal pain, stuffy nose, infections, including seasonal flu, and sore throat.
These are not all the possible side effects of LAMLIQUE. Tell your healthcare provider if you have any side effect that bothers you or that does not go away.
The Important Safety Information does not include all the information needed to use LAMLIQUE safely and effectively. Please see accompanying Full Prescribing Information for LAMLIQUE.
To Report SUSPECTED ADVERSE REACTIONS, contact Azurity Pharmaceuticals, Inc. at 1-800-461-7449, or FDA at 1-800-FDA-1088 or www.fda.gov/MedWatch.
LAMLIQUE™ is a trademark of Azurity Pharmaceuticals, Inc.
©2026 Azurity Pharmaceuticals, Inc.
References:
1. U.S. Centers for Disease Control and Prevention, Epilepsy, https://www.cdc.gov/epilepsy/data-research/facts-stats/index.html?utm_source=chatgpt.com. Accessed September 21, 2026.
About Azurity Pharmaceuticals
Azurity Pharmaceuticals is a privately held global pharmaceutical company dedicated to redefining medicine for the real world. Azurity’s first-in-class enterprise model challenges the status quo by rethinking how therapies are designed, delivered, and accessed. With more than 70 medicines across 11 therapeutic areas, Azurity’s mission is fueled by a growing portfolio that reaches millions of people in more than 50 countries. Learn more at www.azurity.com and follow on LinkedIn.
Media Contact: media@azurity.com
LamliqueTM is a trademark of Azurity Pharmaceuticals, Inc. This press release may contain forward-looking statements subject to risks and uncertainties; actual results may differ materially.
©2026 Azurity Pharmaceuticals, Inc.
PP-LAMQ-8784-US-EN-v1 09/26
Media Relations Azurity Pharmaceuticals media@azurity.com
