FDA reviewers say Titan drug dose may be insufficient

Tue Mar 19, 2013 10:47am EDT

A view shows the U.S. Food and Drug Administration (FDA) headquarters in Silver Spring, Maryland August 14, 2012. REUTERS/Jason Reed

A view shows the U.S. Food and Drug Administration (FDA) headquarters in Silver Spring, Maryland August 14, 2012.

Credit: Reuters/Jason Reed

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(Reuters) - Titan Pharmaceuticals Inc's experimental drug to treat opioid addiction was shown to be more effective than placebo in a clinical trial, but patients' response suggested that the proposed dosage might be too low, reviewers for the U.S. Food and Drug Administration said in documents published on Tuesday.

The commentary was published on the FDA's website ahead of an advisory panel meeting to be held on Thursday and sent the company's stock down 42 percent to $1.19 in over-the counter trading.

The reviewers said they would ask the advisory panel whether Titan should explore dosing further before the product is approved.

The drug, Probuphine, is a long-acting version of buprenorphine, a drug sold by Britain's Reckitt-Benckiser Group Plc under the brand names Subutex and Suboxone.

Unlike Subutex and Suboxone, which are dissolved daily under the tongue, Titan's drug is implanted under the skin of the upper arm during a 10-15 minute office procedure and delivers a continuous supply of buprenorphine for six months.

"Overall, the response was not what one might hope for, given that the product ensures compliance with the medication for six months," the reviewers said. "It prompts speculation that the dose is simply not high enough."

While the safety of Probuphine appears largely in keeping that of other buprenorphine products it presents an additional safety concern, reviewers said. It must be implanted, potentially leading to surgery-related complications. The reviewers said the product is in some ways similar to Norplant, an implantable, progestin-releasing contraceptive which is no longer marketed in the United States.

Even though insertion and removal of Norplant was performed by trained health-care providers, there were cases of implantation and removal-related of complications, some with disabling consequences, the reviewers said. They will ask the advisory committee whether it believes the company has adequately addressed these concerns under its proposed risk mitigation plan and whether the drug's benefit is enough to outweigh the potential risks.

In December, Titan licensed the U.S. and Canadian rights to Probuphine to Braeburn Pharmaceuticals, a company owned by the venture capital firm Apple Tree Partners. Titan received an up-front payment of $15.75 million and will receive up to $50 million if Probuphine is approved.

(Reporting by Toni Clarke in Washington; Editing by Gerald E. McCormick and Alden Bentley)

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Comments (1)
ralphla54 wrote:
It met its end points of the trial. It was non inferior. Did it cure a small % in 6 months yes. Did it cure a large % in 6 months NO and neither does any other opioid treatment.

Yes a small % does not respond so that is an excuse not to put into the market. After one more insert was in place then then about 12% did not respond.

So whatr to do with a treatement taht cannot be forgotten nor misdirected of sold or overdosed? Nope lets get rid of it until we find something that is perfect and works on everyone.

In the mean time Oxicotton addiction has exploded and the number of people under 52 that die of overdoses is the largest cause of death.

What is really going on here is that the ARNA stock traded for less than 10 cents in the OTC market. At that time naked shorting took place that cannot/is not tracked and the number of out standing shares is probably three times the official shares. What to do when several hundred million fake shares were sold at 10 cents and now the company is not going bankrupt. I know get to people in the FDA and make sure the company is driven into BK since the FDA may ask for several new trails. If that does not work then they should ask for even more trials at the next review cycle. See how the financial industry is not only destroying itself but new innovative companies in their cradles.

Mar 20, 2013 11:36am EDT  --  Report as abuse
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