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News

Innocoll begins dosing in second US Phase 2 clinical trial of post-operative pain implant

Innocoll Technologies : 14 March, 2008  (Company News)
Innocoll Technologies has commenced dosing in the second of a series of planned phase 2 clinical trials to investigate CollaRx Bupivacaine surgical implant for the management of post-operative pain.
Innocoll's Bupivacaine surgical Implant is a biodegradable and fully bioresorbable matrix of purified fibrillar collagen impregnated with the local anaesthetic, bupivacaine, which has been specifically developed and formulated using Innocoll's proprietary CollaRx sponge technology. The Implant is under development in the USA and Europe for the management of post-operative pain following moderate/major abdominal, gynaecological, abdominal, thoracic, and orthopaedic surgeries.

Post-operative pain is typically controlled with narcotic analgesics such as morphine, but systemic administration of these drugs can result in unfavourable side effects including suppression of breathing, sedation, nausea and vomiting, and can also affect patient recovery.

Innocoll's Bupivacaine surgical Implant is intended to provide pain control directly at the surgical site and thus reduce the level of additional analgesia required following surgery. The collagen matrix naturally biodegrades over a few days and the bupivacaine is released to provide local analgesia for up to 96 hours post- operatively.

A key feature of Innocoll's product is the ability to Implant it directly into the surgical cavity and at different layers within the wound, such as across the peritoneum incision and directly below the skin incision, which enables localised treatment of both the incisional and deep, visceral pain components normally associated with moderate and major surgery. The bioresorbable nature of the collagen matrix also offers significant clinical benefits and convenience advantages over ambulatory infusion pumps often used to provide continuous, long-term analgesia at the site of a surgical wound.

Innocoll has already completed a phase 2 clinical trial in patients undergoing hysterectomy surgery in the absence of gynaecological cancers at Wexham Park Hospital, Slough, UK.

The results of this trial were encouraging, showing evidence of sustained, post-operative analgesia for approximately 96 hours as measured by VAS (visual analogue scale) scores and reduced dependence on systemic morphine administered by PCA (patient- controlled analgesia). This extended action was achieved despite a low total bupivacaine dose (150mg as the hydrochloride salt), which is well below the allowable daily dose and equivalent to that used by some practitioners for a once-off wound infiltration with bupivacaine solution prior to wound closure

For the planned series of phase 2 multi-centred, controlled clinical trials to be performed in the USA, Innocoll has appointed Premier Research Group, a recognised industry leader in clinical research for acute and chronic pain, to co-ordinate up to five trials in a variety of soft and hard tissue procedures; including hysterectomy, herniorrhaphy, open gastrointestinal surgery and orthopaedic surgery.

The first of the trials in patients undergoing abdominal hysterectomy commenced dosing in December 2007. The second trial will compare the analgesic effect of Bupivacaine surgical Implant versus a placebo Implant in patients undergoing open mesh herniorrhaphy at five different US sites.

In addition to hysterectomy and inguinal hernia repair, other surgeries where the product could potentially be used routinely include caesarean section, mastectomy, open gastrointestinal surgery, cholecystectomy, open-heart surgery, vascular surgery, and various orthopaedic surgeries such as hip and knee replacement, bunionectomy, open fracture repair and certain bone Graft procedures. Detailed market research performed independently by LEK Consulting has predicted peak US sales of Bupivacaine surgical Implant nearing $310 million.

Dr Michael Myers, Innocoll's president and chief executive officer commented, 'The dosing of this second phase 2 trial with our Bupivacaine Implant for the management of post-operative pain follows closely behind other phase 2 and phase 3 trials recently initiated with our topically-applied Gentamicin-Collagen sponge for the treatment of infected diabetic foot ulcers and our Gentamicin Surgical Implant for the prevention of surgical site infection. We also have a number of other phase 2 trials that are expected to commence in the near future, confirming our strong commitment to the development of our late stage product portfolio.'
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