Alpharma buoyed by panel decision on Embeda

The US drugmaker developed Embeda to make it harder for the product to be abused by developing a formulation with an extended-release morphine component as well as naltrexone, an opioid antagonist.

When Embeda is taken as directed, it provides pain relief and the naltrexone remains sequestered in the pellet core while passing through the gastrointestinal tract without significant absorption.

However, if the capsule was crushed, chewed or dissolved, which Alpharma says are common approaches abusers use to tamper with the product in order to gain a euphoric effect, the naltrexone is also released, significantly reducing the high delivered by the opioid.

Shares in the company rose 14 per cent after the panel meeting concluded on Friday, even though the advisors noted that the advantage is incremental and does not provide complete protection from abuse.

Ahead of the meeting, the FDA had issued a report questioning whether Alpharma had demonstrated conclusively that Embeda was resistant to abuse. At the heart of its concerns was that Alpharma’s clinical trials did not look at another common method for abusing opioids, namely dissolving the capsule and injecting it. The agency was also concerned about the safety of naltrexone to patients.

The positive outcome from the panel meeting could also revive efforts by King Pharmaceuticals to acquire Alpharma and boost its presence in the pain management market. King’s $1.55bn offer for Alpharma was turned down in September.

King is also trying to bring an abuse-resistant opioid analgesic product to market, and last Thursday its oxycodone-based Remoxy candidate came up against the same FDA panel, with mixed results.

Remoxy is formulated as a liquid in a gelatine capsule that uses a high-viscosity base component, sucrose acetate isobutyrate (SAIB), to control the release of drug's active ingredient over a period of 12 to 24 hours. That formulation reduces the chance of ‘dose-dumping’ to achieve euphoria if the product is crushed or dissolved. King licenses the from Pain Therapeutics.

The FDA committee was also hesitant about Remoxy’s deterrent effect. While most panellists agreed that the product was less vulnerable to abuse based on clinical trial data, a number disagreed.

The FDA is due to deliver a verdict on the two products by December 10.