Generic Clobazam Tablets, Oral Suspension Receives FDA Approval for Lennox-Gastaut Syndrome

October 24, 2018

The approval and immediate launch of the product in both tablet and oral suspension offer a generic alternative to Onfi.

The FDA has approved abbreviated new drug applications for several companies including Breckenridge Pharmaceutical, Amneal Pharmaceuticals and Upsher-Smith, among others, to immediately market a generic version of clobazam (Onfi) (Lundbeck) tablets, CIV, 10 mg and 20 mg, and clobazam oral suspension, CIV, 2.5 mg/mL, for adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome in patients 2 years of age and older. 1. 2. 3.

Companies such as Amneal and Upsher-Smith have received approval to market clobazam tablets and clobazam oral suspension, while Breckenridge will only market clobazam tablets.

Clobazam’s exact mechanism of action is not fully understood, however, it’s thought to involve the potentiation of GABAergic neurotransmission, a result from binding at the benzodiazepine site of the GABAA receptor.6

Currently marketed as Onfi, the branded medication available in the United States as 10 mg and 20 mg tablets, as well as 2.5 mg/mL oral suspension and was first approved in October 2011 by the FDA for use as adjunctive therapy for the treatment of Lennox-Gastaut Syndrome in patients 2 years of age and older based on 2 randomized, controlled trials. Both studies were similar in terms of disease characteristics and concomitant antiepileptic drug treatments (valproate, lamotrigine, levetiracetam and topiramate). The most common adverse effects that occur at least 10% more frequently than placebo in any clobazam dose included constipation, somnolence or sedation, pyrexia, lethargy and drooling.6 The safety and effectiveness in patients younger than 2 years of age have not yet been established.

According to industry sales data, the branded Onfi clobazam tablets generated annual sales of approximately $594 million throughout 12 months ending Aug. 31, 2018, while clobazam oral suspension generated an estimated $255 million.

The companies have already initiated commercialization activities for these generic products.

“Amneal is pleased to receive approval on our clobazam tablets and clobazam oral suspensions abbreviate new drugs applications,” Andy Boyer, executive vice president of commercial operations, Amneal, said in a statement. “We have immediately initiated commercial activities for these first-to-market generic products.”2

REFERENCE

1. Breckenridge Announces Final Approval of its ANDA for Clobazam Tablets (Generic for Onfi) [news release]. Boca Raton, Fla.: Breckenridge Pharmaceutical, Inc.; Oct. 23, 2018. https://www.prnewswire.com/news-releases/breckenridge-announces-final-approval-of-its-anda-for-clobazam-tablets-generic-for-onfi-300736236.html. Accessed Oct. 24, 2018.

2. Amneal Announces Approval and Launch of Clobazam Tablets and Clobazam Oral Suspension [news release]. Bridgewater, N.J.: Amneal Pharmaceuticals, Inc.; Oct. 24, 2018. https://www.prnewswire.com/news-releases/amneal-announces-approval-and-launch-of-clobazam-tablets-and-clobazam-oral-suspension-300735847.html. Accessed Oct. 24, 2018.

3. Upsher-Smith Launches Generic Version Of Onfi® (clobazam), CIV In Tablet And Oral Suspension Dosage Forms [news release]. Maple Grove, Minn.; Oct. 24, 2018. https://www.prnewswire.com/news-releases/upsher-smith-launches-generic-version-of-onfi-clobazam-civ-in-tablet-and-oral-suspension-dosage-forms-300736510.html. Accessed Oct. 24, 2018.

4. Bionpharma Announces Approval and Launch of Clobazam Tablets and Clobazam Oral Suspension [news release]. Princeton, N.J.; Oct. 23, 2018. https://www.prdistribution.com/news/bionpharma-announces-approval-and-launch-of-clobazam-tablets-and-clobazam-oral-suspension.html. Accessed Oct. 24, 2018.

5. Zydus receives final approval from the USFDA for Clobazam Tablets [news release]. Ahmedabad, India; Oct. 23, 2018. https://zyduscadila.com/public/pdf/pressrelease/Zydus%20receives%20final%20approval%20from%20the%20USFDA%20for%20Clobazam%20Tablets.pdf. Accessed Oct. 24, 2018.

6. CLOBAZAM tablets, for oral use, CIV [prescribing information]. Bridgewater, N.J.: Amneal Pharmaceuticals LLC; 2018. https://www.amneal.com/wp-content/uploads/2018/10/Clobazam-Tablets-PI.pdf. Accessed Oct. 24, 2018.