Cephalon cancels Sparlon development

Cephalon has announced it has withdrawn Sparlon, a new treatment for attention deficit-hyperactivity disorder, from future development.

The move follows the US Food and Drug Administration’s decision not to approve the drug, despite the submission of new data from Cephalon that was hoped would be enough to see the drug attain full approval.

In April, Cephalon submitted new data regarding an incident in clinical trials where one child developed a case of Stevens-Johnson syndrome, a rare but serious skin rash condition. Despite new information compiled by the company after discussions with dermatologists – which concluded that the case was not Stevens-Johnson syndrome – the FDA failed to approve the drug.

Despite the late stage reached in the development of Sparlon, the company has to abandon continued development and cut its losses.

Frank Baldino Jr, chairman and chief executive officer, remarked: “Obviously, we are extremely disappointed and surprised that the agency disagreed with the opinions of our experts, which were based on photographic and other evidence concerning a single suspected case of Stevens-Johnson syndrome.”

Cephalon is also waiting on approval for Nuvigil and Fentora, a sleep disorder treatment and breakthrough cancer pain drug respectively.

The company’s UK headquarters are based in Guildford, Surrey. Cephalon’s UK products comprise Provigil, Gabitril, Actiq and Tegretol Retard.

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