FDA approves AbbVie's Parkinson's drug, featuring delivery straight into the GI tract

The FDA just approved AbbVie's ($ABBV) novel formulation of the standard Parkinson's drugs carbidopa and levodopa, Duopa, which is delivered straight into the patient's small intestine over 16 consecutive hours using an infusion pump and a procedurally placed tube.

In its release, AbbVie explains the benefits of enteral administration, or delivery directly into the gastrointestinal tract, saying that in Parkinson's patients the emptying of the stomach is delayed and unpredictable, affecting the timing of when orally administered medicines are absorbed by the small intestine.

Administration of Duopa is achieved via a percutaneous endoscopic gastrostomy procedure with jejunal extension, which places the tube that facilitates delivery of the drug into the small intestine, thereby bypassing the stomach, AbbVie says.

The combination product was approved for use with the CADD Legacy 1400 pump. It is already available in 41 countries, and is marketed as Duodopa outside the U.S., according to the release.

AbbVie CSO Dr. Michael Severino

"The FDA approval of Duopa is another significant milestone for AbbVie's pipeline," AbbVie Chief Scientific Officer Dr. Michael Severino said in a statement. "This advancement is important for patients with advanced Parkinson's disease and their care teams, as it provides a new therapeutic option to help manage motor symptoms."

The therapy to treat "off" episodes in Parkinson's patients--characterized by slowness, stiffness and difficulty moving--was approved as an orphan drug, meaning it treats a rare disease affecting less than 200,000 patients in the U.S.

Duopa's Phase III clinical trial found that the medication resulted in an almost two-hour-per-day reduction in "off" time compared to standard oral, immediate-release tablets at 12 weeks. The overall reduction in average daily "off" time was four hours.

Oral levodopa/carbidopa's notoriety for unpredictable absorption has set off a mad dash for new delivery methods and reformulations of those drugs. Indeed, the FDA's approval comes on the heels of this month's green light for Impax Laboratories' ($IPXL) Rytary, which contains immediate- and extended-release beads of carbidopa and levodopa.

Another challenge is administering medication in patients with impaired movement. To that end, Impax says that Rytary can be swallowed whole, but for patients who have difficulty swallowing, the drug's capsule can be opened so that the beads can be sprinkled on apple sauce.

However, both medications may someday be supplanted by NeuroDerm's ($NDRM) version of levodopa/carbidopa, which delivers the medication via a wearable belt or patch pump. The company's stock soared earlier this month on the Parkinson's candidate's promising results in Phase IIa clinical trials. Jefferies & Co. analyst Thomas Wei told Reuters that the candidate appears safer or more convenient than both Duopa and Rytary.

Civitas is also scrambling to develop an alternative drug delivery method for levodopa/carbidopa. The Chelsea, MA-based biotech is developing CVT-301, a fast-acting rescue formulation of levodopa that can be self-administered through an inhaler. And Cynapsus is developing reformulated thin-film strip version of the "rescue" drug apomorphine, for patients who don't respond adequately to levodopa/carbidopa alone.

- read the release