Spiroco 4mg Prolonged-release XL Tablets Discontinued

Teva has discontinued Spiroco (ropinirole) 4mg XL prolonged-release tablets due to factors out of the company’s control, according to an announcement from Parkinson’s UK.

The company — which outside the U.S. manufactures ropinirole XL as a generic formulation in three concentrations — is still marketing Spiroco 2mg XL and 8mg XL doses, and the 4mg is available from other manufacturers.

Parkinson’s patients experience a gradual loss of dopamine-producing neurons in the substantia nigra — a region of the brain responsible for movement control — leading up to a series of motor impairments.

Currently, levodopa — a chemical that can be converted to dopamine in the brain — is one of the main medications used to treat motor symptoms (tremors, stiffness, slowness of movement) in those with Parkinson’s.

Its long-term use, however, is linked to the emergence of “off” periods, characterized by the reappearance or worsening of symptoms, and levodopa-induced dyskinesia (LID), in which patients start to experience involuntary muscle movements.

“Off” periods, are more frequent in the morning after awakening, but may occur multiple times throughout the day. These episodes become more frequent and severe as the disease progresses.

Spiroco is Teva’s formulation of ropinirole, an oral dopamine agonist approved as an initial treatment (as monotherapy) for Parkinson’s disease to delay the introduction of levodopa; or in combination with levodopa, over the course of the disease, when the effect of levodopa wears off or becomes inconsistent, reducing the duration of “off” periods. A dopamine agonist is a substance that has similar properties to dopamine and can mimic some of its effects in the brain.

Spiroco XL tablets, taken orally once daily, were designed to release the active ingredient — ropinirole — over a 24-hour period.

In addition to Teva’s 2mg XL and 8mg XL doses, ropinirole is available as an oral therapy from GlaxoSmithKline, brand name Requip, as well as other manufacturers. It also is available as transdermal patches, (Neupro, developed by UCB), which release ropinirole through the skin into the bloodstream over 24 hours.

A new transdermal formulation in which the medication is slowly absorbed through the skin has been developed by Hisamitsu Pharmaceutical. This formulation may increase treatment adherence, since it represents a safer and easier-to-administer option for patients who have difficulties swallowing and eating.