CENTER FOR DRUG EVALUATION AND
`RESEARCH
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`APPLICATION NUMBER:
`022255Orig1s000
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`SUMMARY REVIEW
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`April 19, 2010
`
`Director
`Division of Neurology Products/HFD-120
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`
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`File, NDA 22-255
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`MEMORANDUM
`
`DATE:
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`FROM:
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`
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`TO:
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`SUBJECT: Action Memo for NDA 22-255, for the use of Vimpat (lacosamide)
`Oral Solution, 10 mg/mL and for NDA 22-253/S-006 for Vimpat (lacosamide)
`Tablets & NDA 22-254/S-003, for Vimpat (lacosamide) Injection
`
`NDA 22-255, for the use of Vimpat (lacosamide) Oral Solution, was submitted by
`Schwarz Biosciences, Inc., on 9/27/07. NDAs 22-253 and 22-254, for Vimpat
`Tablets and Injection, respectively, were approved on 10/28/08, for the adjunctive
`treatment of partial seizures in patients aged 17 years and older. NDA 22-255,
`for Vimpat oral solution, submitted at the same time as NDAs 22-253 and 22-
`254, was not approved. Specifically, the Agency issued a Complete Response
`(CR) letter on 10/28/08 for Vimpat Oral Solution because the concentration of the
`solution proposed in that NDA
` did not permit the prescribed
`doses to be achieved accurately.
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`that medication errors could have occurred
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` The Agency was concerned
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`For these reasons, we had proposed that the sponsor develop a solution with a
`different concentration. We noted in the CR letter that the sponsor had
`previously developed a 10 mg/mL syrup, and we implied that such a
`concentration might be more appropriate.
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`The sponsor responded to the CR letter with a complete response on 10/16/09,
`in which they proposed a 10 mg/mL oral solution. This submission has been
`reviewed by Dr. Wendy Wilson-Lee, chemist in the Office of New Drug Quality
`Assessment (ONDQA), Dr. Ramesh Sood, Branch Chief, ONDQA, Dr. Tien-Mien
`Chen, biopharmaceutics reviewer, ONDQA, and Dr. Judy Park, Division of
`Medication Error Prevention and Analysis (DMEPA). The review team
`recommends that the application be approved.
`
` I
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` agree. Adequate chemistry information has been provided, there is no
`requirement that the proposed formulation be shown to be bioequivalent to any
`approved formulation (as Dr. Chen points out, the previous 10 mg/mL formulation
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`1
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`(b) (4)
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`(b) (4)
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`(b) (4)
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`had been shown to be bioequivalent to the tablet, and the solution is essentially
`100% bioavailable), and dosing with the 10 mg/mL solution can be achieved with
`acceptable accuracy with commercially available measuring cups, spoons, etc.
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`The three lacosamide formulations share a common label including a Medication
`Guide, and there is a REMS in place for these products (all anti-epilepsy drugs
`are required to have Medication Guides, and therefore REMS, because of the
`finding of increased suicidality for this class of drugs). Because the Medication
`Guide had to be amended to include a description of the oral solution, the REMS
`needed to be amended. Because the tablets and injection were approved under
`separate NDAs, the REMS needed to be amended for these previous products.
`For this reason, Supplement 006 for the Tablets (NDA 22-253) and Supplement
`003 for the injection (NDA 22-254) were submitted on 8/21/09.
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`For these reasons, I will issue the attached Approval letter for NDA 22-255, and
`for the associated NDAs 22-253/S-006 and 22-254/S-003, with appended
`agreed-upon product labeling.
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`Russell Katz, M.D.
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`2
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`Application
`Type/Number
`--------------------
`NDA-22255
`
`Submission
`Type/Number
`--------------------
`ORIG-1
`
`Submitter Name
`
`Product Name
`
`--------------------
`SCHWARZ
`BIOSCIENCES INC
`
`------------------------------------------
`VIMPAT
`
`---------------------------------------------------------------------------------------------------------
`This is a representation of an electronic record that was signed
`electronically and this page is the manifestation of the electronic
`signature.
`---------------------------------------------------------------------------------------------------------
`/s/
`----------------------------------------------------
`
`RUSSELL G KATZ
`04/20/2010
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`