Hydrocodone chemical structure
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Tussionex

Hydrocodone or dihydrocodeinone (marketed as Vicodin, Anexsia, Dicodid, Hycodan, Hycomine, Lorcet, Lortab, Norco, Tussionex, Vicoprofen) is an opioid derived from either of the naturally occurring opiates codeine or thebaine. Hydrocodone is an orally active narcotic analgesic and antitussive. The typical therapeutic dose of 5 to 10 mg is pharmacologically equivalent to 30 to 60 mg of oral codeine. Sales and production of this drug have increased significantly in recent years, as have diversion and illicit use. more...

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Hydrocodone is commonly available in tablet, capsule and syrup form.

As a narcotic, hydrocodone relieves pain by binding to opioid receptors in the brain and spinal cord. It may be taken with or without food, but should never be combined with alcohol. It may interact with monoamine oxidase inhibitors, as well as other drugs that cause drowsiness. It is in FDA pregnancy category C: its effect on an unborn embryo or fetus is not clearly known and pregnant women should consult their physicians before taking it. Common side effects include dizziness, lightheadedness, nausea, drowsiness, euphoria, vomiting, and constipation. Some less common side effects are allergic reaction, blood disorders, changes in mood, mental fogginess, anxiety, lethargy, difficulty urinating, spasm of the ureter, irregular or depressed respiration and rash.

Hydrocodone can be habit-forming, and can lead to physical and psychological addiction. In the U.S., pure hydrocodone and forms containing more than 15 mg per dosage unit are considered Schedule II drugs. Those containing less than 15 mg per dosage unit are Schedule III drugs. Hydrocodone is typically found in combination with other drugs such as paracetamol (acetaminophen), aspirin and homatropine methylbromide. In the UK it is listed as a Class A drug under the Misuse of Drugs Act 1971.

The presence of acetaminophen in hydrocodone-containing products deters many drug users from taking excessive amounts. However, some users will get around this by extracting a portion of the acetaminophen using hot/cold water, taking advantage of the water-soluble element of the drug. It is not uncommon for addicts to have liver problems from taking excessive amounts of acetaminophen over a long period of time--taking 10–15 grams of acetaminophen in a period of 24 hours typically results in severe hepatotoxicity. It is this factor that leads many addicts to use only single entity opiates such as OxyContin.

Symptoms of hydrocodone overdosage include respiratory depression, extreme somnolence, coma, stupor, cold/clammy skin, sometimes bradycardia, and hypotension. A severe overdose may involve circulatory collapse, cardiac arrest and/or death.

Notes

  1. ^  Tarascon Pocket Pharmacopoeia.

Read more at Wikipedia.org


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UCB confirms positive outlook for 2005
From Market Wire, 12/12/05

UCB confirms its previous guidance that net income after tax for the year to December 31, 2005 will be at least EUR260 million (not including the capital gain of EUR470 million on the sale of the Surface Specialties activities and the operating profit of EUR9 million those activities earned in early 2005). The better than expected sales performance in 2005 and the higher than expected synergies enabled higher Research & Development (R&D) investment and ongoing restructuring charges beyond the previously announced EUR20 million.

This performance reflects the successful transformation of UCB into a pure biopharmaceutical company following the acquisition and integration of Celltech, and divestment of non core activities.

Keppra®, whose sales increase will exceed 30%, is the principal driver of UCB's 2005 sales growth. The allergy franchise continues to grow, driven by Zyrtec® in the U.S.A.([1]) and Japan([2]) and by Xyzal® in Europe, while our mature products are continuing to perform well.

The excellent phase III clinical results of Cimzia (TM) for the treatment of Crohn's disease encouraged UCB to accelerate R&D and launch-preparation investment in this product, contributing to total R&D spend increasing to 25% of net 2005 group sales. All other major R&D programs (except CDP 484 as announced early in the year) have progressed according to plan.

R&D Update

Central Nervous System (CNS)

* Keppra® is confirming its position as the new standard in epilepsy treatment.

Intravenous formulation

Regulatory filings are under review by both EMEA and FDA. The first launch in the first quarter of 2006 is being prepared.

Primary generalised myoclonic seizures

Regulatory filings are under review by both EMEA and FDA. The first launch by mid 2006 is being prepared.

Primary generalised tonic-clonic seizures The submission of the regulatory file is expected by mid 2006.

Monotherapy

The submission of the European regulatory file is expected during the first quarter of 2006.

Japan

The enrollment of the second pivotal phase III study for Keppra in the treatment of epilepsy has started in Japan.

* Brivaracetam and Seletracetam

The phase II clinical studies are evolving according to plan and results are expected in the second half of 2006.

Inflammation

* Cimzia (TM)

Crohn's Disease

The preparation of the regulatory files is on track and expected to be submitted during the first quarter of 2006.

Rheumatoid Arthritis

The two phase III profiling studies are evolving according to plan and first results are expected by the end of 2006.

Psoriasis

A phase III clinical study for the treatment of psoriasis has been initiated and recruitment is ongoing.

* Early Prevention of Asthma in Atopic Children (EPAAC (TM))

The EPAAC (TM) study was designed to explore the efficacy of Xyzal® beyond its already well established indications. This innovative study examined the effectiveness of levocetirizine (Xyzal®) in the prevention of asthma in a subpopulation of very young children with specific family history([3]). The primary endpoint of the study was not met. The preliminary safety analysis confirmed Xyzal®'s good safety profile in very young children.

Oncology

CDP 791([4]), an anti-VEGF receptor-2 monoclonal antibody, is currently in phase II clinical evaluation for the treatment of non small cell lung cancer with results expected by the end of 2006.

Initial Trends for 2006

2006 is expected to be another year of dynamic sales growth, mainly driven by Keppra®. Royalty income, as expected, will be impacted by the expiry of the Boss technology patent.

UCB will significantly increase its investment in Cimzia (TM), which is on track for regulatory filing and is being prepared for launch during the first half of 2007. Other selling, general and administrative expenses will be tightly managed.

We expect R&D investment to increase and be around 25% of sales in 2006, principally driven by:

Final results for 2005 will be announced on March 14th 2006 at which time UCB will also update the market on R&D progress and on the financial outlook for 2006.

Roch Doliveux, CEO of UCB, said, "With the successful integration of Celltech and the tremendous achievements of my UCB colleagues, our first full year of operations as a biopharmaceutical company has been very encouraging, delivering rapid growth and giving us a solid base for 2006 and beyond. 2006 will be a year of continued growth in sales as well as significant investments for the future, including the preparation for the Cimzia (TM) launch and further R&D progress."

About UCB

UCB (www.ucb-group.com) is a global biopharmaceutical leader with headquarters in Brussels, Belgium, specialising in the fields of central nervous system disorders, inflammatory diseases, and oncology. UCB key products are Keppra® (antiepileptic), Xyzal® and Zyrtec® (antiallergics), Nootropil® (cerebral function regulator), Tussionex® (antitussive) and Metadate(TM) / Equasym XL(TM) (attention deficit/hyperactivity disorder). UCB employs over 8,500 people operating in over 40 countries. UCB is listed on Euronext Brussels (UCB / UCBBt.BR / UCB BB).

([1]) UCB co-promotes Zyrtec in the USA with Pfizer.

([2]) Daiichi-Sankyo and GSK Japan are co-distributing Zyrtec in Japan.

([3]) EPAAC (TM) study results: Preventive effect of levocetirizine on the onset of asthma in children aged 1 to 2 a family history of atopy suffering from atopic dermatitis and sensitized to house dust mite and/or grass pollen has not been confirmed.

([4]) UCB and Imclone Systems entered in August 2005 into a development and commercialization partnership for CDP791.

For the pdf-version of this press release, please click on the link below:

http://hugin.info/133973/R/1025070/162731.pdf

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