Depomed warns of Nucynta ER delays citing damage to Puerto Rico CMO

By Gareth Macdonald contact

- Last updated on GMT

Gettyimages/Sergio Lacueva
Gettyimages/Sergio Lacueva

Related tags: Pharmacology

Depomed Inc. says supplies of the extended release version of Nucynta will be delayed as a result of damage to a Puerto Rico manufacturing plant caused by hurricane Maria.

The California, US-based firm announced that the packaging and delivery of certain dosage strengths of Nucynta ER (tapentadol) will be temporarily delayed as a result of ‘minor damage’ to a facility where the drug is made by a contract manufacturer.

Depomed spokesman Christopher Keenan declined to name the contractor involved, but did tell us “it is the same one as J&J had prior to us acquiring the product. We have been working to transition these activities to a new manufacturer and site​.”

Nucynta is used to manage moderate to severe chronic pain in adults. It was developed by German pharmaceutical firm Grünenthal, which licensed production and commercialization rights to Janssen Pharmaceutica NV in 2009​ in return for sales royalties.

Depomed bought US rights to sell the drug in 2015 for $1.05bn.

At the time​ it said: “An affiliate of Janssen Pharma is our sole supplier of Nucynta ER and Nucynta pursuant to a manufacturing supply agreement​.”

An immediate release version of Nucynta is also made in Puerto Rico, however, Depomed said it does not expect any material disruption to production, which it said had recently transferred to a new contractor.

Depomed also said that disruption caused by Hurricane Maria negatively impacted its third quarter revenue by $2 to $3m.

It also predicted that delays to the packaging and delivery of Nucynta ER will cut fourth quarter revenue by less than $10m.

Gralise not impacted

Depomed also provided an update about its epilepsy treatment Gralise (gabapentin) which, like Nucynta, is produced in Puerto Rico.

The firm said that it does not expect supplies of Gralise to be impacted, explaining that it has “has adequate inventory​.”

It also confirmed the drug is made by Patheon NV at its facility in Manito.

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